The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03479905
• Other study ID #: STU 102017-005
• Status: Terminated
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: September 20, 2023

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 143
• Est. completion date: September 20, 2023
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 18-80
• Subjects undergoing colonoscopies
• Morbidly obese BMI equal or greater than 40
• STOPBANG score equal or greater than 5

Exclusion Criteria:

• Subjects deemed hemodynamically unstable by the anesthesia team
• Subjects who are an aspiration risk and will require endotracheal intubation.
• Pregnancy
• Subjects with an allergy to propofol
• Patients who are unable to tolerate the high flow nasal cannula secondary to discomfort
• Subjects unwilling to sign consent
• Patients that received medications other than lidocaine and propofol

Related Conditions & MeSH terms

• Colonoscopy
• Desaturation of Blood

Intervention

Other:
• Salter nasal cannula
Oxygen will be delivered by using standard nasal cannula
• Face mask
Oxygen will be delivered via face mask during colonoscopy

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.

Locations

Country	Name	City	State
United States	Parkland Helath Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation	The frequency of desaturation episodes (SpO2 <90%)	Intraoperative period