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OPTIFLOW: High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia

Sponsor
CMC Ambroise Paré (Other)
Overall Status
Completed
CT.gov ID
NCT03554863
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
2.8
Actual Duration (Months)
30
Patients Per Site
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

  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. Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.

The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow anesthetic induction without having to impose the patient the establishment of a facial mask for several minutes before anesthetic induction and the doctor anesthetist assisted ventilation with the mask before intubation.

Condition or Disease Intervention/Treatment Phase
  • Device: Nasal High Flow Oxygen
  • Device: Facial Mask
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Does Optiflow Anesthesia Allow Anethesia Induction "Without Hands" ?
Actual Study Start Date :
Nov 21, 2018
Actual Primary Completion Date :
Feb 14, 2019
Actual Study Completion Date :
Feb 14, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Facial mask

Device: Facial Mask
Preoxygenation with facial mask
Experimental: Optiflow anesthesia

Device: Nasal High Flow Oxygen
Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel

Outcome Measures

Primary Outcome Measures

  1. Recourse to another ventilation technique [During the preoxygenation-induction-intubation period (30 min)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Consent for participation

  • Affiliation to the french social security system

  • Patients benefit general anesthesia with oral intubation

Exclusion Criteria:

  • 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 a predicted difficulty of mask ventilation or intubation according to the clinical examination prior to inclusion (arne score ≥ 11) or when treating the patient in the operating room;

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CMC Ambroise Paré Neuilly sur seine Ile De France France 92200
2 Hôpital Foch Suresnes Ile De France France 92151

Sponsors and Collaborators

  • CMC Ambroise Paré

Investigators

  • Study Chair: FISCHLER Marc, MD, Hôpital FOCH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CMC Ambroise Paré
ClinicalTrials.gov Identifier:
NCT03554863
Other Study ID Numbers:
  • 2017/01
First Posted:
Jun 13, 2018
Last Update Posted:
Mar 5, 2019
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CMC Ambroise Paré
Anesthesia genral, Oxygen

Study Results

No Results Posted as of Mar 5, 2019