High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia

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.

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Key information

Conditions

Anesthesia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMC Ambroise Paré, Neuilly-sur-Seine, Île-de-France Region, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal High Flow Oxygen

Device

Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel

Facial Mask

Device

Preoxygenation with facial mask

Primary outcomes

Recourse to another ventilation technique

Time frame: 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.

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study title

Does Optiflow Anesthesia Allow Anethesia Induction "Without Hands" ?

Acronym: OPTIFLOW

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jun 13, 2018
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed