Supplemental Oxygen for Apnea During Colonoscopy

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TS
Overseen ByTrey S Blackwell, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Utah
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 examines different methods of providing extra oxygen to individuals undergoing a colonoscopy. Researchers aim to determine which method best prevents breathing pauses and low oxygen levels during the procedure. The trial tests three methods: the usual constant oxygen flow (supplemental oxygen), a new device that delivers oxygen only during inhalation (breath-synchronized oxygen), and a mask that applies pressure to keep airways open (CPAP). This trial involves adult patients without life-threatening conditions who are undergoing a colonoscopy with sedation at the University of Utah Health clinic in South Jordan, Utah. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance the safety and comfort of colonoscopies.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that these oxygen delivery methods are safe for colonoscopy patients?

Research shows that synchronized flow oxygen therapy, using the FDA-approved Sovant device, reduces breathing interruptions and drops in oxygen levels. In a previous study, an incident of interrupted breathing caused only a slight decrease in blood oxygen, indicating that this method is generally safe and well-tolerated.

For CPAP therapy, studies have demonstrated its ability to lower the risk of low oxygen levels during procedures. Specifically, one study found that CPAP reduced low oxygen incidents from 25.3% to 7.6% in patients undergoing endoscopy. This suggests CPAP could be a safer choice for managing oxygen levels during sedation.

Overall, both synchronized oxygen flow and CPAP therapy have shown promising safety in research, making them potentially safe options for patients concerned about breathing interruptions and low oxygen during procedures.12345

Why are researchers excited about this trial?

Researchers are excited about the trial of supplemental oxygen techniques for apnea during colonoscopy because it explores innovative ways to improve patient safety and comfort. The Synchronized Oxygen Flow arm uses a breath-synchronized delivery system, which pulses oxygen at the start of inhalation, potentially reducing oxygen waste and improving efficiency. Meanwhile, the CPAP arm utilizes continuous positive airway pressure to maintain airway openness, automatically adjusting oxygen flow to ensure optimal pressure. These advanced delivery methods could enhance breathing support during procedures compared to the traditional continuous oxygen flow, potentially leading to better outcomes and patient experiences.

What evidence suggests that this trial's methods of supplemental oxygen delivery could be effective for reducing apnea and oxygen desaturation during colonoscopy?

This trial will compare different methods of oxygen delivery during colonoscopy. Research has shown that CPAP, one of the methods tested in this trial, can significantly reduce the risk of low oxygen levels during procedures. In one study, CPAP lowered the chance of low blood oxygen from 25.3% to 7.6% in patients. Another method under study, the Sovant device, provides oxygen only during inhalation, which can help improve oxygen levels during sedation. Although specific data on using these devices during colonoscopies is limited, they have effectively maintained stable oxygen levels in other medical situations. Overall, both CPAP and these oxygen-delivery devices have shown promise in reducing breathing problems during procedures.12345

Who Is on the Research Team?

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Kai Kuck, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for adults having a colonoscopy with sedation at the University of Utah Health clinic in South Jordan, who do not have life-threatening conditions.

Inclusion Criteria

I am having a colonoscopy with sedation at the South Jordan, Utah clinic.
I am an adult.
* No life threatening conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive supplemental oxygen using one of three methods: continuous flow, synchronized flow, or CPAP therapy during colonoscopy procedures

Duration of the procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Breath-synchronized oxygen
  • CPAP
  • Supplemental Oxygen

Trial Overview

The study compares three ways to give oxygen during sedated colonoscopies: standard continuous flow (regular oxygen), breath-synchronized pulses (oxygen given only when you inhale), and CPAP (a mask that keeps airways open). The goal is to see which method best prevents low oxygen events.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Synchronized Oxygen FlowExperimental Treatment1 Intervention
Group II: CPAPExperimental Treatment1 Intervention
Group III: Continuous Oxygen FlowActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Citations

Nasal Continuous Positive Airway Pressure to Reduce ...

Nasal continuous positive airway pressure (CPAP) reduced hypoxia incidence (7.6% vs 25.3%) and stabilized oxygen levels during endoscopy in obese patients.

Duration-Dependent Risk of Hypoxemia in Colonoscopy ...

A recent study suggested that high-flow nasal oxygen (HFNO) might offer superior outcomes in maintaining adequate oxygen levels during ...

Supplemental Oxygen for Apnea During Colonoscopy

The hypothesis being tested is that synchronized flow delivery and CPAP therapy will demonstrate reductions in apnea and oxygen desaturation ...

Feasibility of breath monitoring in patients undergoing elective ...

In one case, an apnea registered by the respiR8™ device led to a relative SaO2 reduction of 5% within the physiologic range (from 98% to 93%) after a lag time ...

The Effect of High-flow Nasal Oxygenation to the Saturation ...

Investigators expect that patients who receive HFNO will better maintain adequate oxygenation regarding improved spontaneous breathing. Also patients will have ...