The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients
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|ClinicalTrials.gov Identifier: NCT03479905|
Recruitment Status : Suspended (COVID-19 policy)
First Posted : March 27, 2018
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Desaturation of Blood Colonoscopy||Other: Salter nasal cannula Other: Face mask Device: High Flow Nasal Cannula||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized Trial Comparing the Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients With High Risk of Obstructive Sleep Apnea Undergoing Colonoscopy|
|Actual Study Start Date :||March 5, 2018|
|Estimated Primary Completion Date :||April 25, 2021|
|Estimated Study Completion Date :||November 25, 2021|
Sham Comparator: Salter nasal cannula
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
Oxygen will be delivered by using standard nasal cannula
Other Name: Sedler Nasal Cannula
Sham Comparator: Face mask group
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 via face mask during colonoscopy
Other Name: Standard Face Mask
Experimental: High Floow Oxygen delivery
Oxygen will be delivered by using high flow nasal cannula
Device: High Flow Nasal Cannula
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.
Other Name: Device The Comfort Flo system
- Oxygen saturation [ Time Frame: Intraoperative period ]The frequency of desaturation episodes (SpO2 <90%)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479905
|United States, Texas|
|Parkland Helath Hospital System|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Christina Riccio, MD||UT Southwestern Medical Center|