High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia (OPTIFLOW)

Does Optiflow Anesthesia Allow Anethesia Induction "Without Hands" ?

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: Facial Mask; Device: Nasal High Flow Oxygen

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Neuilly sur seine, Ile De France, France, 92200
      • CMC Ambroise Paré
    • Suresnes, Ile De France, France, 92151
      • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré
• Investigators: Study Chair: FISCHLER Marc, MD, Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Anesthesia genral, Oxygen
• Other Study ID Numbers: 2017/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No