High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia

NCT ID: NCT03554863

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2019-02-14

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Facial mask

Group Type: ACTIVE_COMPARATOR

Facial Mask

Intervention Type: DEVICE

Preoxygenation with facial mask

Optiflow anesthesia

Group Type: EXPERIMENTAL

Nasal High Flow Oxygen

Intervention Type: DEVICE

Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel

Interventions

Nasal High Flow Oxygen

Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel

Intervention Type: DEVICE

Facial Mask

Preoxygenation with facial mask

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

FISCHLER Marc, MD

Role: STUDY_CHAIR

Hôpital FOCH

Locations

CMC Ambroise Paré

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

Hôpital Foch

Suresnes, Île-de-France Region, France

Countries

France

Other Identifiers

2017/01

Identifier Type: -

Identifier Source: org_study_id