High-Flow Nasal Cannula and Desaturation Episodes in the Morbidly Obese Patients

NCT03148262 | Completed Results FDA Device

• 1 other identifier: STU 112016-058
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

It is standard practice in the United States and many parts of world to perform Gastrointestinal (GI) endoscopy with the patient under deep 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 and the standard nasal cannula in morbidly obese (BMI \> 40) patients receiving deep intravenous sedation during colonoscopies. This study will assess whether use of the high flow nasal cannula (HFNC) leads to less intraoperative desaturation events compared to the current standard of care.

Conditions

Desaturation of Blood; Obesity; Colonoscopy; Sleep Apnea; High Flow Nasal Cannula

Outcome Measures

Primary Outcomes (1)

• The Number of Desaturation Episodes

  The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.

  Perioperative period during colonoscopy

Study Arms (2)

The high flow nasal cannula

EXPERIMENTAL

The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy

Device: The Comfort Flo system

The standard nasal cannula

PLACEBO COMPARATOR

The Salter nasal cannula will be used during the colonoscopy

Device: The Salter nasal cannula

Interventions

The Comfort Flo system DEVICE

The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation

Also known as: High flow nasal cannula

The high flow nasal cannula

The Salter nasal cannula DEVICE

A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.

Also known as: Standard nasal cannula

The standard nasal cannula

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 ≥ 40

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
• Chronic obstructive pulmonary disease
• Patients that received medications other than lidocaine and propofol

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Parkland Helath Hospital System

Dallas, Texas, 75390, United States

Location

Parkland Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Obesity; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. Christina Riccio
• Organization: UT Southwestern Medical Center

Christina.Riccio@UTSouthwestern.edu

214-590-7284

Study Officials

• Amanda Fox, MD

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: May 10, 2017
• Primary Completion: August 28, 2017
• Study Completion: January 22, 2018
• Last Updated: November 19, 2018
• Results First Posted: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)