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

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ClinicalTrials.gov Identifier: NCT03615417
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Francesco Ricottilli, MD, Erasme University Hospital

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
Preoxygenation Anesthesia Obesity Device: High Flow Nasal Cannula (HFNC) Device: Standard anesthesia FaceMask (FM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 19, 2018
Actual Primary Completion Date : September 7, 2018
Actual Study Completion Date : September 7, 2018

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.





Primary Outcome Measures :
  1. Functional Residual Capacity (FRC) variation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 20 minutes ]
    The lowest SpO2 (%) during general anesthesia induction (from a base period to the mechanical ventilation).

  3. Preoxygenation Comfort [ Time Frame: 6 hours ]
    The subjective comfort of the patient during the preoxygenation, expressed with a 0-5 scale at Post Anesthesia Care Unit (PACU) discharge.



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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:

  • 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

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): NCT03615417


Locations
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Belgium
Erasme University Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Francesco Ricottilli, MD Erasme University Hospital
Publications:

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Responsible Party: Francesco Ricottilli, MD, Resident, Department of Anesthesiology, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03615417    
Other Study ID Numbers: SRB-201712-161
B406201834736 ( Other Identifier: CCB - Comité consultatif de Bioéthique de Belgique )
P2018/067 ( Other Identifier: Erasme - ULB Ethics Committee )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs