An interventional study of Salter nasal cannula and Face mask in Desaturation of Blood and Colonoscopy, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention
It is standard practice in the United States and many parts of world to perform Gastrointestinal endoscopy with the patient under deep intravenous sedation. Obesity is accepted as a patient specific risk factor for hypoxic events during procedural sedation for GI endoscopic procedures. The obese population has a higher prevalence of obstructive sleep apnea (OSA), which is characterized by repeated obstruction of the upper airway, and leads to apnea and desaturation. This prospective, randomized study was designed to compare the effectiveness of the high flow nasal cannula, standard nasal cannula and standard face mask in morbidly obese patients with a high risk of sleep apnea, (BMI greater than 40, STOPBANG greater or equal to 5) receiving deep intravenous sedation during colonoscopies. This study will assess which method leads to a lower incidence of intraoperative desaturation events compared to the current standard of care.
The prevalence of morbid obesity is increasing worldwide. As the severity of obesity increases, the incidence of diagnosed obstructive sleep apnea also rises. Studies have shown an incidence of sleep apnea as high as 64% in patients with a body mass index (BMI) over 40 and 100% in patients with a BMI greater than 60. Patients with OSA have been shown to have significant desaturations under intravenous sedation due to airway narrowing and obstruction. Several studies have also shown that morbidly obese subjects, independent of a diagnosis of OSA, run a higher perioperative risk of adverse airway events, including hypoxia. Providing anesthesia for this patient population is challenging and requires careful titration of drugs and superb airway management skills.
The current standard of care for oxygen delivery in this setting is a Salter nasal cannula. Humidified high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21% to 100% FiO2 delivery and generates up to 60 L/min flow rates. The gas is heated (35 to 40 degree Celsius) and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the subject through a large diameter nasal cannula. Theoretically, HFNC offers significant advantages in oxygenation and ventilation over conventional methods. Constant high flow oxygen delivery provides steady inspired oxygen fraction (FiO2) and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation.
Some studies have demonstrated a positive effect of HFNC on the apnea-hypopnea index (AHI) showing that use of HFNC could decrease hypoxic episodes in subjects with repetitive upper airway obstruction such as obstructive sleep apnea. The STOP-BANG questionnaire (SB) has been used successfully to screen patients undergoing therapeutic endoscopic procedures at higher risk for sedation-related adverse events.
University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.
Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36%
Other: Salter nasal cannula
A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%.
Other: Face mask
Oxygen will be delivered by using high flow nasal cannula
Device: High Flow Nasal Cannula
Oxygen will be delivered via standard nasal cannula during colonoscopy
Oxygen will be delivered via face mask during colonoscopy
Also known as: Standard Face Mask
A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.
Also known as: Device The Comfort Flo system
Oxygen Saturation (SpO2 )
The frequency of desaturation episodes (SpO2 \<90%)
Time frame: Intraoperative period, an average of 1 hour
| Milestone | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery |
|---|---|---|---|
| Started | 47 | 48 | 48 |
| Completed | 43 | 43 | 43 |
| Not completed | 4 | 5 | 5 |
| Withdrew: Other airway method used | 4 | 5 | 5 |
The frequency of desaturation episodes (SpO2 \<90%)
| Desaturation episodes | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery |
|---|---|---|---|
| Oxygen Saturation (SpO2 ) | 0 (0 to 2) | 0 (0 to 1) | 0 (0 to 0) |
Collected over During hospital stay, an average of 6 hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Salter Nasal Cannula | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Face Mask Group | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| High Flow Oxygen Delivery | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Age, Continuous(years) | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery | Total |
|---|---|---|---|---|
| Mean | 56.55 ± 8.10 | 58.23 ± 6.73 | 57.55 ± 10.04 | 57.44 ± 8.36 |
| Sex: Female, Male(Participants) | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery | Total |
|---|---|---|---|---|
| Female | 28 | 31 | 28 | 87 |
| Male | 15 | 12 | 15 | 42 |
| Ethnicity (NIH/OMB)(Participants) | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery | Total |
|---|---|---|---|---|
| Hispanic or Latino | 11 | 12 | 10 | 33 |
| Not Hispanic or Latino | 30 | 31 | 32 | 93 |
| Unknown or Not Reported | 2 | 0 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 21 | 22 | 19 | 62 |
| White | 20 | 21 | 23 | 64 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 1 | 3 |
| Region of Enrollment(participants) | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery | Total |
|---|---|---|---|---|
| United States | 43 | 43 | 43 | 129 |
| Stop Bang Score(Stop Bang Score on a scale of 0 to 8) | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery | Total |
|---|---|---|---|---|
| Median | 6 (6 to 7) | 6 (5 to 7) | 6 (5 to 7) | 6 (5 to 7) |
| Preoperative oxygen saturation (SpO2)(Percentage of oxygen saturation) | Salter Nasal Cannula | Face Mask Group | High Flow Oxygen Delivery | Total |
|---|---|---|---|---|
| Median | 97.5 (96 to 98) | 98 (96 to 99) | 97 (96 to 98) | 98 (96 to 98) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas Southwestern Medical Center →