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HFNC Versus Conventional Nasal Cannula in Oxygen Performance in Patients Receiving Colonoscopy Under IV Sedation (HFNC)

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ClinicalTrials.gov Identifier: NCT02968706
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Aventura Hospital and Medical Center

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.

Condition or disease Intervention/treatment Phase
Desaturation of Blood Device: High Flow Nasal Cannula Device: Conventional Nasal Cannula Other: Patient satisfaction questionnaire Not Applicable

Detailed Description:

Intravenous sedation during colonoscopy has become the standard practice in United States given its higher patient satisfaction and procedural quality. The most common used short acting sedative agent is propofol. Although possessing safe and rapidly reversed pharmacokinetic properties, propofol intravenous infusion can lead to respiratory depression and hypoxemia. In one prospective study, hypoxemia events, defined by oxygen saturation less than 90 percent was found in 20 percent of patients receiving colonoscopy using propofol sedation. The mechanism of hypoxemia is mainly hypoventilation, airway collapse, and carbon dioxide (CO2) retention. When it comes to gastrointestinal procedures, using oxygen devices for augmenting ventilation is usually avoided, ex: positive pressure ventilation, since it can lead to bowel distention and affect quality of procedures. Therefore most hospitals in United States still use nasal cannula of oxygen therapy during gastrointestinal procedures, and there is lack of available options of oxygen therapy which can improve hypoventilation and prevent hypoxemia.

High flow nasal cannula (HFNC) is a new generation of oxygen therapy. It provides constant high flow oxygen delivery with heated and humidified air. Moreover, it has been studied that high velocity of airflow can create the effect of "positive end expiratory pressure" thus assist ventilation and work of breathing. Compared to conventional nasal cannula and face mask, HFNC has demonstrated superior performance in oxygenation, work of breathing and patient comfort in many studies. Since its invention, HFNC has been studied in post-cardiac surgery, post-extubation, bronchoscopy and dental procedures and all of them show equal to better oxygen performance in comparison of nasal cannula.

While capnographic monitoring has been studied to prevent hypoxemia during sedation, no studies have been done to evaluate the clinical utility of new generation oxygen therapy. Obesity is associated with increased frequency of sedation related complications especially hypoxemia during propofol mediated sedation for advanced endoscopic procedures. The Investigators hypothesized that HFNC may improve oxygen performance compared to conventional nasal cannula for obese patients receiving colonoscopy under intravenous sedation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: High Flow Nasal Cannula Versus Conventional Nasal Cannula in Oxygen Performance in Patients Receiving Colonoscopy Under Intravenous Sedation
Actual Study Start Date : January 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: High Flow Nasal Cannula
Heated humidified high flow oxygen of 50 L/min at FiO2 of 40%
Other Name: High flow oxygen delivering device (OPTIFLO)

Other: Patient satisfaction questionnaire
Questionnaire

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.
Device: Conventional Nasal Cannula
Supplemental oxygen of 2-5 L/min

Other: Patient satisfaction questionnaire
Questionnaire




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Incidence rate of carbon dioxide retention (end tidal CO2 more than 50 mmHg at any time of procedure) [ Time Frame: Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy) ]
  2. Patients satisfaction level (patient comfort and mouth dryness assessed by a questionnaire with 4-scale questions) [ Time Frame: One time point (15 minutes after the patient recovered from anesthesia sedation) ]
  3. Respiratory rates before and after colonoscopy procedure, and highest respiratory rate during colonoscopy procedure. [ Time Frame: Three time points (Before, through out, and within 5 minutes after the colonoscopy procedure) ]
  4. Incidence rate of hypoxia rescue intervention events (e.g. jaw lift, anterior mandibular shifting, head elevation ) [ Time Frame: Through out the colonoscopy procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT02968706


Contacts
Contact: Hilda Mahmoudi, MD, MPH (305) 682 7261 Hilda.Mahmoudi@hcahealthcare.com

Locations
United States, Florida
Aventura Hospital and Medical Center Recruiting
Aventura, Florida, United States, 33180
Contact: Hilda Mahmoudi, MD, MPH    305-682-7261    Hilda.mahmoudi@hcahealthcare.com   
Contact: Jestin Pudussery Kattalan, MD       Jestin.PudusseryKattalan@hcahealthcare.com   
Sponsors and Collaborators
Aventura Hospital and Medical Center
Investigators
Principal Investigator: Hilda Mahmoudi, MD, MPH Aventura Hospital and Medical Center

Responsible Party: Aventura Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT02968706     History of Changes
Other Study ID Numbers: 2016-516
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aventura Hospital and Medical Center:
High Flow Nasal Cannula
Colonoscopy
Obesity