Pulse Oximetry Accuracy During Surgery

JR
CR
Overseen ByCatherine Roth, MPH
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Joseph D. Tobias
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure blood oxygen levels during surgery using a device placed in the mouth. It compares this method to the standard finger or toe sensor and evaluates how both align with a blood test. The goal is to determine if the mouth method is as accurate and reliable as traditional pulse oximetry methods, which non-invasively monitor a patient's blood oxygen saturation. The trial seeks participants undergoing surgery with general anesthesia who require an arterial cannula for blood pressure monitoring.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical monitoring techniques.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for measuring pulse oximetry during surgery?

Research has shown that using a pulse oximeter in the throat area is generally well-tolerated. One study found that the accuracy of readings from the throat was similar to those taken from the fingers or toes, with a difference of about 2-4%, which is considered acceptable.

However, like all pulse oximeters, there is a small risk of burns, especially in infants or people with poor blood flow. This risk is rare and manageable. Overall, studies suggest that using a pulse oximeter in the throat is safe during surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the use of oropharyngeal pulse oximetry during surgery because it offers a unique way to monitor oxygen levels. Unlike the traditional method of attaching a pulse oximeter to a finger or earlobe, this technique places the device in the oropharynx, which could potentially provide more accurate readings during surgery when blood flow to the extremities might be compromised. This could lead to better patient outcomes by ensuring more reliable monitoring of oxygen levels in real-time.

What evidence suggests that oropharyngeal oximetry is effective for measuring pulse oximetry during surgery?

Research has shown that an oropharyngeal pulse oximeter, which participants in this trial will use, provides reliable oxygen level readings. Studies have found that this type of oximeter shows a small difference of about 4.2 ± 3.4 compared to readings from a finger or toe. One study found it to be very accurate, with a bias of less than 0.5%. Oropharyngeal oximetry also proves more accurate than finger oximetry, especially when blood flow is low. This suggests that the oropharyngeal oximeter is a promising tool for monitoring oxygen levels during surgery.26789

Are You a Good Fit for This Trial?

This trial is for patients who are undergoing surgery with general anesthesia and need an arterial cannula, a small tube inserted into an artery. It's not for those with mouth injuries or diseases, if they can't use a standard finger pulse oximeter, have restricted access to their throat, or don't need the arterial tube for their surgery.

Inclusion Criteria

I am having surgery under general anesthesia and need a special type of IV.

Exclusion Criteria

Patients in whom an arterial cannula is not indicated for the surgical procedure
Patients in whom a peripheral pulse oximeter value cannot be obtained
Patients in whom an invasive arterial cannula cannot be placed
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Measurement

Baseline measurements of pulse oximetry readings from peripheral and oropharyngeal sites

1 day
1 visit (in-person)

Comparison and Analysis

Comparison of pulse oximetry readings from different sites and analysis against arterial blood gas measurements

1-2 weeks

Follow-up

Participants are monitored for any immediate post-measurement effects

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Pulse Oximetry
Trial Overview The study tests if doctors can get good oxygen level readings from inside the throat using regular pulse oximetry equipment attached to oral tools like airways or tongue depressors. These readings will be compared to those from traditional sites like fingers and toes and checked against blood gas results.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Oropharyngeal oximetryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joseph D. Tobias

Lead Sponsor

Trials
24
Recruited
4,000+

Citations

Clinical evaluation for the pharyngeal oxygen saturation ...The pharyngeal SpO2 has a clinically acceptable bias, which is less than 0.5% with high precision, which is less than 2%.
Successful use of pharyngeal pulse oximetry with ...Pharyngeal oxygen saturation with the oropharyngeal airway is feasible and more accurate than finger oximetry in low perfusion states.
Feasibility of Obtaining Pulse Oximetry Readings From the ...The oropharyngeal oximeter functioned effectively with an absolute difference from the extremity values of 4.2 ± 3.4 in cohort 1 and 2.5 ± 3.4 ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40742001/
Feasibility of Obtaining Pulse Oximetry Readings From the ...Results: The oropharyngeal oximeter functioned effectively with an absolute difference from the extremity values of 4.2 ± 3.4 in cohort 1 and ...
Accuracy of pharyngeal pulse oximetry with different ...Conclusion: Pharyngeal oximetry is feasible and generally more accurate than finger oximetry. The application of pharyngeal oximetry with COPA ...
Feasibility of Obtaining Pulse Oximetry Readings From the ...The oropharyngeal oximeter functioned effectively with an absolute difference from the extremity values of 4.2 ± 3.4 in cohort 1 and 2.5 ± 3.4 ...
Clinical evaluation for the pharyngeal oxygen saturation ...Its accuracy is ± 2% for oxygen saturation ranges from 90 to 100%, and ± 3% for oxygen saturation ranges from 70 to 89%. According to the FDA it ...
In Response : A&A PracticeIt should be understood that all pulse oximeters have a risk to burn patients and should be monitored for these risks. Infants, patients with poor peripheral ...
Pulse Oximetry Accuracy During SurgeryThis is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been ...
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