Recruiting

HFNC vs. Cannula

Sponsor:

Aventura Hospital and Medical Center

Code:

NCT02968706

Conditions

Desaturation of Blood

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Flow Nasal Cannula

Conventional Nasal Cannula

Patient satisfaction questionnaire

Study Details

Brief summary:

The purpose of this study is to investigate if high flow nasal cannula (HFNC), as compared to conventional nasal cannula, improves oxygenation and prevents desaturation events in obese patients undergoing colonoscopy.

Conditions

Desaturation of Blood

Study ID

NCT02968706

Start date

Jan, 2017

Status verified date

Feb, 2017

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • BMI ≥ 30.
  • Age ≥ 18 years.
  • ASA classification II and III.
  • Scheduled for colonoscopy.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Allergic to propofol and any of its contents.
  • Baseline SpO2 less than 93%.
  • Patients who require intubation for airway protection based on anesthesiologist discretion.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High flow cannula arm

Patients in the experimental arm (the high flow nasal cannula group) will receive heated humidified high flow oxygen of 50L/min at FiO2 of 40% throughout the colonoscopy. A patient satisfaction survey will be administered after procedure.

active comparator: Conventional cannula arm

Participants in control arm (the conventional nasal cannula group) will receive an oxygen flow of 2-5 L /min. A patient satisfaction survey will be administered after procedure.

Interventions

High Flow Nasal Cannula

Heated humidified high flow oxygen of 50 L/min at FiO2 of 40%

Conventional Nasal Cannula

Supplemental oxygen of 2-5 L/min

Patient satisfaction questionnaire

Questionnaire

Primary outcome measure

  • Incidence rate of desaturation events during procedures (desaturation events are defined by either SpO2 drops more than 5% compared to baseline SpO2 OR SpO2<90% at any time of procedures) [ Time Frame: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy) ]

Central Contacts and Locations

Central contacts

Hilda Mahmoudi, MD, MPH

(305) 682 7261Hilda.Mahmoudi@hcahealthcare.com

Locations

Aventura Hospital and Medical Center

Recruiting

Aventura, Florida, United States, 33180

Contacts

Hilda Mahmoudi, MD, MPH

305-682-7261Hilda.mahmoudi@hcahealthcare.com

Jestin Pudussery Kattalan, MD

Jestin.PudusseryKattalan@hcahealthcare.com

More Information

Sponsor

Aventura Hospital and Medical Center

Last update posted

Feb 20, 2017

Last verified

Feb, 2017

Keywords

  • High Flow Nasal Cannula
  • Colonoscopy
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aventura Hospital and Medical Center on 2017-02-20.