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High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia

Sponsor
Erasme University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03615417
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
4.6
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the effectiveness of the High Flow Nasal Cannula (HFNC) for the preoxygenation of obese patients undergoing a general anesthesia. The HFNC interface is compared to a standard anesthesia FaceMask (FM) preoxygenation with Continuous Positive Airway Pressure (CPAP), the current gold standard procedure for obese induction.

The interest of HFNC preoxygenation is to increase the "safe apnea time" before critical arterial desaturation, useful in the management of difficult airways, especially in subjects with reduced respiratory reserves such as the obese.

Condition or Disease Intervention/Treatment Phase
  • Device: High Flow Nasal Cannula (HFNC)
  • Device: Standard anesthesia FaceMask (FM)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effectiveness of High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia: A Randomised Controlled Trial
Actual Study Start Date :
Apr 19, 2018
Actual Primary Completion Date :
Sep 7, 2018
Actual Study Completion Date :
Sep 7, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: HFNC - High Flow Nasal Cannula

Participants are preoxygenated by High Flow Nasal Cannula (HFNC) OptiFlow.

Device: High Flow Nasal Cannula (HFNC)
Preoxygenation trough High Flow Nasal Cannula (HFNC) at 100% FiO2, 50 liters/min and closed mouth. After Rapid Sequence Induction (RSI), maintenance of apnea with HFNC at 100% FiO2, 70 liters/min and jaw thrust. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated.
Other Names:
  • THRIVE
  • OptiFlow

    		•
    Active Comparator: FM - FaceMask

    Participants are preoxygenated by standard anesthesia FaceMask.

    Device: Standard anesthesia FaceMask (FM)
    Preoxygenation trough standard anesthesia FaceMask (FM) at 100% FiO2, 12 liters/min, CPAP 7 cmH2O. After Rapid Sequence Induction (RSI), maintenance of apnea without mask. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated.

    Outcome Measures

    Primary Outcome Measures

    1. Functional Residual Capacity (FRC) variation [20 minutes]

      The difference of FRC, estimated by lung Electrical Impedance Tomography (EIT), during general anesthesia induction (from a base period to the mechanical ventilation).

    Secondary Outcome Measures

    1. Time of safe apnea [20 minutes]

      The time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%, or the apnea time reaches 600 seconds.

    2. Lowest SpO2 [20 minutes]

      The lowest SpO2 (%) during general anesthesia induction (from a base period to the mechanical ventilation).

    3. Preoxygenation Comfort [6 hours]

      The subjective comfort of the patient during the preoxygenation, expressed with a 0-5 scale at Post Anesthesia Care Unit (PACU) discharge.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Surgery with the need for general anesthesia with muscle relaxation

    • ASA (American Society of Anesthesiologists) physical status score II-III

    • BMI > 35

    Exclusion Criteria:

    • Severe respiratory disease (acute respiratory failure, Chronic obstructive pulmonary disease COPD, parenchymal pneumopathies,...)

    • Severe nasal pathology (malformation, stenosis)

    • Criteria or previous difficult intubation

    • BMI > 50

    • Chest circumference > 150cm

    • Implanted electronic device (pacemaker, neurostimulator, ...)

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erasme University Hospital Brussels Belgium 1070

    Sponsors and Collaborators

    • Erasme University Hospital

    Investigators

    • Principal Investigator: Francesco Ricottilli, MD, Erasme University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Francesco Ricottilli, MD, Resident, Department of Anesthesiology, Erasme University Hospital
    ClinicalTrials.gov Identifier:
    NCT03615417
    Other Study ID Numbers:
    • SRB-201712-161
    • B406201834736
    • P2018/067
    First Posted:
    Aug 3, 2018
    Last Update Posted:
    Nov 19, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Anesthetics

    Study Results

    No Results Posted as of Nov 19, 2018