Supplemental Oxygen for Apnea During Colonoscopy
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive supplemental oxygen using one of three methods: continuous flow, synchronized flow, or CPAP therapy during colonoscopy procedures
Follow-up
Participants are monitored for safety and effectiveness after the procedure
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
This arm is breath-synchronized oxygen delivery with the FDA-cleared Sovant oxygen delivery device through a nasal cannula or non-rebreather mask. Oxygen is pulsed at the beginning of the patient's inhalation and flow is discontinued the rest of the breath.
This arm is oxygen delivery through continuous positive airway pressure (CPAP) therapy administered by an investigational device, where oxygen is given through a tight-fitting mask over the patient's mouth and nose. The oxygen flow rate is automatically adjusted by the device to maintain a set pressure in the patient's airway as selected by the anesthetist.
This arm is the traditional supplemental oxygen delivery of providing a continuous oxygen flow through a nasal cannula or non-rebreather oxygen mask at a flow rate set by the anesthetist.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
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 ...
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