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Project 2 - Clinical Investigation Plan

General: Pulse oximetry is a noninvasive test that measures the oxygen saturation level of your blood. It can rapidly detect even small changes in oxygen levels. These levels show how efficiently blood is carrying oxygen to the extremities furthest from your heart, including your arms and legs. The pulse oximeter is a…

ADVAITH MENON
updated on 04 Jan 2023

General:

Pulse oximetry is a noninvasive test that measures the oxygen saturation level of your blood.

It can rapidly detect even small changes in oxygen levels. These levels show how efficiently blood is carrying oxygen to the extremities furthest from your heart, including your arms and legs.

The pulse oximeter is a small, clip-like device. It attaches to a body part, most commonly to a finger.

Medical professionals often use them in critical care settings like emergency rooms or hospitals. Some doctors, such as pulmonologists, may use them in office settings. You can even use one at home.

Purpose and uses

The purpose of pulse oximetry is to see if your blood is well oxygenated.

Medical professionals may use pulse oximeters to monitor the health of people with conditions that affect blood oxygen levels, especially while they’re in the hospital.

These can include:

chronic obstructive pulmonary disease (COPD)
asthma
pneumonia
lung cancer
anemia
heart attack or heart failure
congenital heart disease

IDENTIFICATION AND DEESCRIPTION OF THE DEVICE:

A pulse oximeter is a medical device that measures your oxygen saturation, or the percentage of oxygen in your blood. The device can be used to help detect and manage certain medical conditions such as sleep apnea or heart failure

The principle of pulse oximetry is based on the differential absorption characteristics of oxygenated and the de-oxygenated hemoglobin. Oxygenated hemoglobin absorbs more infrared light and allows more red light to pass through. Whereas Deoxygenated hemoglobin absorbs more red light and allowing more infrared light to pass through.
Each pulse oximeter sensor probe contains two light emitting diode one emitting red light and the other emitting near infrared light, it also has a photo-detector. The photo-detector measures the intensity of transmitted light at each wavelength. And using the differences in the reading the blood oxygen content is calculated. The probe is placed on a suitable part of the body, usually a fingertip or ear lobe.
Transmission Method

In the transmission method the transmitter i.e. the LED & the receiver i.e. the photo-detector are placed on opposite side of the finger. In this method this finger will be placed between the LED’s & the photo-detector. When the finger is placed a part of the light will be absorbed by the finger and some part will reach the photo detector. Now with each heart beat there will be increase in volume of blood flow this will result in more light getting absorbed by the finger so less light reaches the photo-detector.
Hence if we see the waveform of received light signal it will consist of peaks in between heart beats and trough (bottom) at each heartbeat. This difference between the trough & the peak value is the reflection value due to blood flow at heart beat.
Reflectance Method
In Reflective method the LED & the photo-detector are placed on the same side i.e. next to each other.In the reflective method there will be some fixed light reflection back to the sensor due to finger. With each heart-beat there will be an increase in blood volume in the finger this will result in more light reflection back to the sensor.

Hence if we see the waveform of the received light signal it will consist of peaks at each heartbeat. A fixed low value reading is there in between the heart beats this value can be considered as constant reflection and this difference of the peak subtracted from the constant reflection value is the reflection value due to blood flow at heart beat.

In both above cases you can see the troughs/peaks in reflected light occur at each heartbeat the duration between two spikes can be used to measure the persons Heart Rate. Hence a typical heart beat sensor Module consists of only on Transmitter LED (mostly infrared) and one photo-detector.
HISTORY AND JUSTIFICATION :

With modern, sophisticated pulse oximetry technology, a doctor can determine a patient’s blood oxygenation levels almost instantly by putting a small instrument on a patient’s finger. In the mid-to-late 1800s, things weren’t so easy, and scientists had barely just learned the body’s method of absorbing oxygen and distributing it throughout the body.

The seeds of modern pulse oximetry were planted in 1840 when Friedrich Ludwig Hunefeld, a member of the German Biochemistry Association, discovered crystalline structures in the blood that transports oxygen. The crystals were hemoglobin, a term that Felix Hoppe-Seyler coined in 1864. Hoppe-Seyler’s investigations on hemoglobin would spur George Gabriel Stokes, an Irish-English mathematician and physicist, to look into “the reduction and oxidation of the colouring matter of the blood.” Before their experiments, scientists knew that blood carries oxygen, but they weren’t sure if it was dissolved in the blood or bound to a substance that carried it along.

In separate experiments and investigations, Stokes and Hoppe-Seyler figured out how to answer this question with an experiment: if oxygen were simply dissolved in the blood, its presence or absence in blood wouldn’t noticeably affect the way that light passes through it. But if oxygen were chemically bound to a molecule in the bloodstream, light would behave differently when hitting oxygen-rich and oxygen-poor blood.

The scientists hypothesized that hemoglobin bound to oxygen would reflect a different wavelength of light—and therefore a different color—than hemoglobin that’s not. This means that blood should change color when oxygen is added or taken away from it.

When Stokes and Hoppe-Seyler exposed blood with varying oxygenation levels to light, they found different wavelengths of light were emitted from oxygen-rich and oxygen-poor blood, and that the same blood sample could change its color when exposed to different levels of oxygen. This proved definitively that hemoglobin binds to oxygen.

This realization wasn’t enough to give us the modern pulse oximeter. At the time Stokes and Hoppe-Seyler conducted their experiments, the only way to measure the oxygenation level of a patient’s blood was still to extract a blood sample and analyze it. This method was painful, invasive, and too slow to give doctors enough time to act on the information it provided.

The fundamental principle of modern pulse oximeters has been discovered. What followed then was a series of significant breakthroughs in creating a device capable of measuring how much oxygen is in the blood.

Doctors use pulse oximetry for a number of different reasons, including:

to assess how well a new lung medication is working
to evaluate whether someone needs help breathing
to evaluate how helpful a ventilator is
to monitor oxygen levels during or after surgical procedures that require sedation
to determine whether someone needs supplemental oxygen therapy
to determine how effective supplemental oxygen therapy is, especially when treatment is new
to assess someone’s ability to tolerate increased physical activity
to evaluate whether someone momentarily stops breathing while sleeping — like in cases of sleep apnea — during a sleep study

Pulse oximetry tests are an estimation of blood oxygen levels, but they’re typically precise. This is especially true when using high quality equipment found in most medical offices or hospital settings. With this equipment, medical professionals can carry out the tests accurately.

The Food and Drug Administration (FDA)Trusted Source requires that prescription oximeters must provide results within an accuracy range of 4 to 6 percent.

The American Thoracic SocietyTrusted Source says that typically, more than 89 percent of your blood should be carrying oxygen. This is the oxygen saturation level needed to keep your cells healthy.

Having an oxygen saturation temporarily below this level may not cause damage. But repeated or consistent instances of lowered oxygen saturation levels may be damaging.

An oxygen saturation level of 95 percent is considered typical for most healthy people. A level of 92 percent or lower can indicate potential hypoxemia, which is a seriously low level of oxygen in the blood.

Various factors can affect readings, including a person’s skin tone.

A 2020 report compared the accuracy of pulse oximetry tests and blood gas measurements in detecting hypoxemia in Black and white patients.

Researchers found that among Black patients, there were three times as many cases of pulse oximetry tests failing to detect occult hypoxemia when blood gas measurements did so.

Tests like these were developed without considering a diversity of skin tones. The authors concluded that more research is needed to understand and correct this racial bias.

A pulse oximeter is a device that is usually placed on a fingertip. It uses light beams to estimate the oxygen saturation of the blood and the pulse rate. Oxygen saturation gives information about the amount of oxygen carried in the blood. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.

Most pulse oximeters show two or three numbers. The most important number, oxygen saturation level, is usually abbreviated SpO₂, and is presented as a percentage. The pulse rate (similar to heart rate) is abbreviated PR, and sometimes there is a third number for strength of the signal. Oxygen saturation values are between 95% and 100% for most healthy individuals, but sometimes can be lower in people with lung problems. Oxygen saturation levels are also generally slightly lower for those living at higher altitudes.

There are two categories of pulse oximeters: prescription use and over the counter (OTC).

Prescription oximeters are reviewed by the FDA, receive 510(k) clearance, and are available only with a prescription. The FDA requires that these pulse oximeters undergo clinical testing to confirm their accuracy. They are most often used in hospitals and doctors’ offices, although they may sometimes be prescribed for home use.
Over-the-counter (OTC) oximeters are sold directly to consumers in stores or online and include smart phone apps developed for the purpose of estimating oxygen saturation. Use of OTC oximeters has increased as a result of the COVID-19 pandemic. These products are sold as either general wellness or sporting/aviation products that are not intended for medical purposes, so they do not undergo FDA review. OTC oximeters are not cleared by the FDA and should not be used for medical purposes.

For more information on pulse oximeter regulation, see Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff.

Interpretation and Limitations of Pulse Oximetry

Pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. In many cases, the level of inaccuracy may be small and not clinically meaningful; however, there is a risk that an inaccurate measurement may result in unrecognized low oxygen saturation levels. Therefore, it is important to understand the limitations of pulse oximetry and how accuracy is calculated and interpreted.

FDA-cleared prescription pulse oximeters are required to have a minimum average (mean) accuracy that is demonstrated by desaturation studies done on healthy patients. This testing compares the pulse oximeter saturation readings to arterial blood gas saturation readings for values between 70-100%. The typical accuracy (reported as Accuracy Root Mean Square or A_rms) of recently FDA-cleared pulse oximeters is within 2 to 3% of arterial blood gas values. This generally means that during testing, about 66% of SpO₂ values were within 2 or 3% of blood gas values and about 95% of SpO₂ values were within 4 to 6% of blood gas values, respectively.

However, real-world accuracy may differ from accuracy in the lab setting. While reported accuracy is an average of all patients in the test sample, there are individual variations among patients. The SpO₂ reading should always be considered an estimate of oxygen saturation. For example, if an FDA-cleared pulse oximeter reads 90%, then the true oxygen saturation in the blood is generally between 86-94%. Pulse oximeter accuracy is highest at saturations of 90-100%, intermediate at 80-90%, and lowest below 80%. Due to accuracy limitations at the individual level, SpO₂ provides more utility for trends over time instead of absolute thresholds. Additionally, the FDA only reviews the accuracy of prescription use oximeters, not OTC oximeters meant for general wellness or sporting/aviation purposes.

Many patient factors may also affect the accuracy of the measurement. The most current scientific evidence shows that there are some accuracy differences in pulse oximeters between dark and light skin pigmentation; this difference is typically small at saturations above 80% and greater when saturations are less than 80%. In the recently published correspondence by Sjoding, et. al.External Link Disclaimer, the authors reported that Black patients had nearly three times the frequency of occult hypoxemia (low oxygen levels in the blood) as detected by blood gas measurements but not detected by pulse oximetry, when compared to White patients. It is important to note that this retrospective study had some limitations. It relied on previously collected health record data from hospital inpatient stays and could not statistically correct for all potentially important confounding factors. However, the FDA agrees that these findings highlight a need to further evaluate and understand the association between skin pigmentation and oximeter accuracy.

All premarket submissions for prescription use oximeters are reviewed by the FDA to ensure that clinical study samples are demographically representative of the U.S. population, as recommended by FDA guidance, Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff. As described in this guidance, FDA recommends that every clinical study have participants with a range of skin pigmentations, including at least 2 darkly pigmented participants or 15% of the participant pool, whichever is larger. Although these clinical studies are not statistically powered to detect differences in accuracy between demographic groups, the FDA has continued to review the effects of skin pigmentation on the accuracy of these devices, including data from controlled laboratory studies and data from real world settings.

IDENTIFICATION AND DEESCRIPTION OF THE DEVICE:

The principle of pulse oximetry is based on the differential absorption characteristics of oxygenated and the de-oxygenated hemoglobin. Oxygenated hemoglobin absorbs more infrared light and allows more red light to pass through. Whereas Deoxygenated hemoglobin absorbs more red light and allowing more infrared light to pass through.

Each pulse oximeter sensor probe contains two light emitting diode one emitting red light and the other emitting near infrared light, it also has a photo-detector. The photo-detector measures the intensity of transmitted light at each wavelength. And using the differences in the reading the blood oxygen content is calculated. The probe is placed on a suitable part of the body, usually a fingertip or ear lobe.

Transmission Method

In the transmission method the transmitter i.e. the LED & the receiver i.e. the photo-detector are placed on opposite side of the finger. In this method this finger will be placed between the LED’s & the photo-detector. When the finger is placed a part of the light will be absorbed by the finger and some part will reach the photo detector. Now with each heart beat there will be increase in volume of blood flow this will result in more light getting absorbed by the finger so less light reaches the photo-detector.

Hence if we see the waveform of received light signal it will consist of peaks in between heart beats and trough (bottom) at each heartbeat. This difference between the trough & the peak value is the reflection value due to blood flow at heart beat.

Reflectance Method

In Reflective method the LED & the photo-detector are placed on the same side i.e. next to each other.In the reflective method there will be some fixed light reflection back to the sensor due to finger. With each heart-beat there will be an increase in blood volume in the finger this will result in more light reflection back to the sensor.

In both above cases you can see the troughs/peaks in reflected light occur at each heartbeat the duration between two spikes can be used to measure the persons Heart Rate. Hence a typical heart beat sensor Module consists of only on Transmitter LED (mostly infrared) and one photo-detector.

IDENTIFICATION AND DEESCRIPTION OF THE DEVICE:

Now ssince we know that any changes in the clinical investigation cannot be done without priorly informing and also without the approval of ethics committee and the central licensing authority except when it is neccessary to eliminate immediate hazards to the study subject or when the changes involve only logistic or administrative aspects of investigation.All such exceptions shall beimmediately notified to the ethics committe as well as central licensing authority.

name of the manufacturer/sponsor/company	Medtronics	Exact corrective measure taken	exact preventive measure taken
Medical Device	Pulse oximeter
Date of corrective measure	10-06-2018	use of multiple wavelengths of light	signal proccessing technique using filter bank
Date of preventive measure	2-04-2018
Justification		enables the analysis of different haemoglobin's in blood	Removing Motion artifact

OBJECTIVE:

The aim of the clinical investigation plan is to make sure that the pulse oximeter that has been manufactured and is out in the market has to be every effective,non faulty and safe .

RISK AND BENEFITS:

Pulse oximeter is a non invasive medical device and belongs to the classIIa,as it is a non invasive device which produce minimal risk

BENEFITS

These Pulse Oximeters are used for people who have various issues that affect their oxygen saturation levels. For instance, a sleep specialist might tell you to get a Pulse Oximeter, which should be used to check the amount of oxygen used by a loved one suspected of suffering from either severe snoring or the process when one stops breathing while they sleep.

Pulse Oximetry helps in providing information that talks about the efficiency of interventions while breathing. These include ventilators and therapy using oxygen.

Some doctors use pulse oximetry to check out how safe people’s physical activity should be when they suffer from problems in their respiratory or cardiovascular system. These doctors recommend that these people make use of a pulse oximeter as they exercise. In addition, doctors could make use of these pulse oximeters as a stress test part.

Several hospitals make use of these pulse oximeters for vulnerable patients. For example, little children in intensive neonatal care units could wear these pulse oximeters, telling staff if there’s a little oxygen saturation drop.

Whenever there’s any oxygen drop, infants using these pulse oximeters would get detected when any change occurs.

RISKS

The following conditions may make the pulse oximeter reading unreliable.

Poor peripheral perfusion (shock, vasoconstriction, hypotension). Do not attach the sensing probe onto an injured extremity. Try not to use the sensing probe on the same arm that you are using to monitor the blood pressure. Be aware that the pulse oximeter reading will go down while the blood pressure cuff is inflated.
Severe anemia
Carbon Monoxide (CO) poisoning. This will give falsely high readings because the sensing probe cannot distinguish between oxyhemoglobin and carboxyhemoglobin.
Hypothermia
Excessive patient movement
High ambient light (bright sunlight, high-intensity light on the area of the sensing probe).
Nail polish or a dirty fingernail if you are using a finger probe. Use acetone to clean the nail before attaching the probe.

BENEFITS:

lt benefits of pulse oximeter include the following;

Checking the rate of oxygen saturation through time
Detecting and alerting others on low oxygen levels, especially in newborns.
I am offering high levels of peace to people suffering from cardiovascular or respiratory problems.
Showing someone if they need extra levels of oxygen
Checking the oxygen saturation levels for people that have passed out because they are sedated.
It was indicating horrible side effects from people that are on medications that affect oxygen or breathing saturation.

Plan:

1.Approval for clinical investigation

2.Responsibilities of sponsor

3.Responsibilities of Investigator

4.Responsibilities of Ethics Commitee

5.Informed Consent

6.Pilot Clinical Investigation

7.Pivotal Clinical Investigation

8.Post Marketing Clinical Investigation

9.Studies in special population

10.Post Marketing Survellence

Data Management:

A case of data management regarding pulse oximeter is as follows-:

Screening for congenital heart defects relies on antenatal ultrasonography and postnatal clinical examination; however, life-threatening defects often are not detected. We prospectively assessed the accuracy of pulse oximetry as a screening test for congenital heart defects.

Findings 20 055 newborn babies were screened and 53 had major congenital heart disease (24 critical), a prevalence of 2·6 per 1000 livebirths. Analyses were done on all babies for whom a pulse oximetry reading was obtained. Sensitivity of pulse oximetry was 75·00% (95% CI 53·29–90·23) for critical cases and 49·06% (35·06–63·16) for all major congenital heart defects. In 35 cases, congenital heart defects were already suspected after antenatal ultrasonography, and exclusion of these reduced the sensitivity to 58·33% (27·67–84·83) for critical cases and 28·57% (14·64–46·30) for all cases of major congenital heart defects. False-positive results were noted for 169 (0·8%) babies (speciﬁcity 99·16%, 99·02–99·28), of which six cases were signiﬁcant, but not major, congenital heart defects, and 40 were other illnesses that required urgent medical intervention.

The main outcome was the accuracy (sensitivity and speciﬁcity) of detection of major congenital heart defects, subgrouped into critical (ie, death or requiring invasive intervention before 28 days) and major congenital heart disease (ie, death or requiring invasive intervention before 12 months of age). The sample size was calculated by use of simulation with estimates from our systematic review of pulse oximetry.26 Based on a prevalence of congenital heart defects of two per 1000, for an assumed sensitivity of 75% and speciﬁcity of 99·5%, a sample size of 20 000 babies provided 80% power to prove the sensitivity was at least 52% and more than 90% power to prove the speciﬁcity was greater than 99·3% (both by use of a one-sided α=2·5%).

A vulnerable population is a group of people that requires greater protection than normal against the potential risks of participating in research. Individuals in vulnerable populations may have a higher risk of negative outcomes as a result of participating in a research study, they may have a reduced capacity or ability to give consent, or they may (for other reasons) have special legal protections. Below is a list of populations that Institutional Review Boards (IRBs) commonly consider to be vulnerable:

Children (i.e., minors or individuals under the legal age of consent)
Individuals who are incarcerated (i.e., prisoners)
Residents of a facility (such as a mental health facility, nursing home, treatment center, etc.)
Individuals with a life-threatening illness or condition (e.g., cancer, HIV/AIDS)
Individuals with a debilitating mental health condition or cognitive impairment
Pregnant women
Victims of traumatic events (e.g., abuse, natural disasters)
Individuals involved in a crisis (e.g., war, natural disaster)
Individuals who are economically disadvantaged
Individuals who are not fluent in the language the study is being conducted in (e.g., non-English speakers in studies conducted in the United States)
Elderly individuals (e.g., 65 years old or older)
Subordinates of the researcher (e.g., students, employees)

If you are studying a vulnerable population, the IRB will often require you to have specific procedures in place to protect your participants. For instance, if you are studying children, you will need to have procedures for obtaining assent from the child, as well as consent from their parent or legal guardian. In any research involving vulnerable populations, the IRB will heavily scrutinize your study, not only in terms of its procedures but also its merit. In other words, you will need to demonstrate to the IRB that your study procedures are ethically sound, that the risks to participants are as minimal as possible, and that the scientific contributions and potential benefits of your study are significant enough to warrant exposing vulnerable individuals to the risks and burden of research participation.

case study :For measuring the accuracy of the pulse oximeter ,20 babies were included in the study,as the law states these babies were incuded in the study only after taking consent from theeir respective parents or legal guardian, no other vurnerable groups were part of this case study.

Moreover,since the medical device which is the pulse oximeter,consist of minimal risk,the adverse affect regarding the study was informed to the parents or legal guardian.

Circumstances may lead to the temporary halt or early termination of a clinical investigation with a medical device. You are required to notify the review committee of any temporary halt or early termination of a clinical investigation with a medical device. In some cases you are also required to inform CCMO because of its role as the competent authority for clinical investigations with medical devices.

Device concered	date of termination	reason of termination
pulse oximeter	04-09-2018	poor sensitivity of pulse oximeter

Document review:

Document Name	Made by:	Reviewed by:	Authorised by
Clinical Investigation Report
Date:

It informs us the which is the document being reviewed,who actually made the document,once the document is filled out, it has to be reviwed by someone to check whether the information which is filled is relevant or not,Moreover ,it specifies the person who is supposed to authorize the document.