NCT03554863

Brief Summary

Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management.

  1. 1.The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of hypoxemia during the apnea phase and intubation maneuvers. It consists of applying a mask on the patient's face and allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95% corresponds to a "total" alveolar oxygenation. When this value is reached, the injection of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of consciousness and apnea, which forces to continue the manual ventilation to the mask. Intubation is performed when the myorelaxation is complete.
  2. 2.Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

May 15, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

May 15, 2018

Last Update Submit

April 2, 2026

Conditions

Anesthesia

Keywords

Anesthesia genral, Oxygen

Outcome Measures

Primary Outcomes (1)

  • Recourse to another ventilation technique

    The preoxygenation-induction-intubation period is filmed (audio and video recording) and the use of mask ventilation will be confirmed a posteriori from the audio / video recording by two reviewers.

    During the preoxygenation-induction-intubation period (30 min)

Study Arms (2)

Facial mask

ACTIVE COMPARATOR
Device: Facial Mask

Optiflow anesthesia

EXPERIMENTAL
Device: Nasal High Flow Oxygen

Interventions

Nasal High Flow OxygenDEVICE

Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel

Optiflow anesthesia
Facial MaskDEVICE

Preoxygenation with facial mask

Facial mask

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consent for participation
  • Affiliation to the french social security system
  • Patients benefit general anesthesia with oral intubation

You may not qualify if:

  • Pregnant or breastfeeding patients;
  • Patients with difficulty of ventilation by Optiflow AnesthesiaTM (facial trauma);
  • Patients under the protection of justice
  • Patients with drained or undrained pneumothorax;
  • Patients with coronary heart disease, heart failure or respiratory failure;
  • Patients with intracranial pathology; patients with arterial oxygen saturation \<95% in the open air;
  • Patients for whom the surgical procedure requires the installation of a double-lumen tube;
  • Patients requiring rapid sequence induction; patients for whom the induction can not be carried out by the sequence sufentanil, propofol, rocuronium;
  • Patients with sugammadex allergy;
  • Patients placed under judicial protection
  • Patients who have already been included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Hôpital Foch

Suresnes, Île-de-France Region, 92151, France

Location

Related Publications (1)

  • Tremey B, Squara P, De Labarre H, Ma S, Fischler M, Lawkoune JD, Le Guen M. Hands-free induction of general anesthesia: a randomised pilot study comparing usual care and high-flow nasal oxygen. Minerva Anestesiol. 2020 Nov;86(11):1135-1142. doi: 10.23736/S0375-9393.20.14456-0. Epub 2020 Jul 8.

    PMID: 32643359RESULT

Study Officials

  • FISCHLER Marc, MD

    Hôpital FOCH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 13, 2018

Study Start

November 21, 2018

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)