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

NCT ID: NCT02968706

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-10-31

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.

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.

Conditions

Desaturation of Blood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

High Flow Nasal Cannula

Intervention Type: DEVICE

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

Patient satisfaction questionnaire

Intervention Type: OTHER

Questionnaire

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.

Group Type: ACTIVE_COMPARATOR

Conventional Nasal Cannula

Intervention Type: DEVICE

Supplemental oxygen of 2-5 L/min

Patient satisfaction questionnaire

Intervention Type: OTHER

Questionnaire

Interventions

High Flow Nasal Cannula

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

Intervention Type: DEVICE

Conventional Nasal Cannula

Supplemental oxygen of 2-5 L/min

Intervention Type: DEVICE

Patient satisfaction questionnaire

Questionnaire

Intervention Type: OTHER

Other Intervention Names

High flow oxygen delivering device (OPTIFLO)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aventura Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilda Mahmoudi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Aventura Hospital and Medical Center

Locations

Aventura Hospital and Medical Center

Aventura, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hilda Mahmoudi, MD, MPH

Role: CONTACT

Hilda.Mahmoudi@hcahealthcare.com

(305) 682 7261

Facility Contacts

Hilda Mahmoudi, MD, MPH

Role: primary

Hilda.mahmoudi@hcahealthcare.com

305-682-7261

Jestin Pudussery Kattalan, MD

Role: backup

Jestin.PudusseryKattalan@hcahealthcare.com

Other Identifiers

2016-516

Identifier Type: -

Identifier Source: org_study_id