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

NCT03479905 | Terminated Results DMC FDA Device

• 1 other identifier: STU 102017-005
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Desaturation of Blood; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation (SpO2 )

  The frequency of desaturation episodes (SpO2 \<90%)

  Intraoperative period, an average of 1 hour

Study Arms (3)

Salter nasal cannula

SHAM COMPARATOR

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

Face mask group

SHAM COMPARATOR

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

High Flow Oxygen delivery

EXPERIMENTAL

Oxygen will be delivered by using high flow nasal cannula

Device: High Flow Nasal Cannula

Interventions

Salter nasal cannula OTHER

Oxygen will be delivered via standard nasal cannula during colonoscopy

Salter nasal cannula

Face mask OTHER

Oxygen will be delivered via face mask during colonoscopy

Also known as: Standard Face Mask

Face mask group

High Flow Nasal Cannula DEVICE

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

High Flow Oxygen delivery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Helath Hospital System

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Christina Riccio
• Organization: UTexasSouthwestern

Christina.Riccio@utsouthwestern.edu

214-590-7284

Study Officials

• Christina Riccio, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: March 5, 2018
• Primary Completion: January 7, 2020
• Study Completion: September 20, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)