NCT02968706

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

November 8, 2016

Last Update Submit

February 17, 2017

Conditions

Desaturation of Blood

Keywords

High Flow Nasal CannulaColonoscopyObesity

Outcome Measures

Primary Outcomes (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)

    Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)

Secondary Outcomes (4)

  • Incidence rate of carbon dioxide retention (end tidal CO2 more than 50 mmHg at any time of procedure)

    Through out the colonoscopy procedure (after propofol induction to the end of colonoscopy)

  • Patients satisfaction level (patient comfort and mouth dryness assessed by a questionnaire with 4-scale questions)

    One time point (15 minutes after the patient recovered from anesthesia sedation)

  • Respiratory rates before and after colonoscopy procedure, and highest respiratory rate during colonoscopy procedure.

    Three time points (Before, through out, and within 5 minutes after the colonoscopy procedure)

  • Incidence rate of hypoxia rescue intervention events (e.g. jaw lift, anterior mandibular shifting, head elevation )

    Through out the colonoscopy procedure

Study Arms (2)

High flow cannula arm

EXPERIMENTAL

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 CannulaOther: Patient satisfaction questionnaire

Conventional cannula arm

ACTIVE COMPARATOR

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 CannulaOther: Patient satisfaction questionnaire

Interventions

High Flow Nasal CannulaDEVICE

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

Also known as: High flow oxygen delivering device (OPTIFLO)
High flow cannula arm
Conventional Nasal CannulaDEVICE

Supplemental oxygen of 2-5 L/min

Conventional cannula arm
Patient satisfaction questionnaireOTHER

Questionnaire

Conventional cannula armHigh flow cannula arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aventura Hospital and Medical Center

Aventura, Florida, 33180, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hilda Mahmoudi, MD, MPH

    Aventura Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilda Mahmoudi, MD, MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 21, 2016

Study Start

January 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

February 20, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)