Conventional Oxygen Therapy Versus Continuous Transnasal High Flow Oxygen Therapy for Head and Neck Diagnostic Panendoscopy Under General Anesthesia in Spontaneous Ventilation

NCT05696288 | Completed DMC

• 1 other identifier: 2022/16
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The high-flow oxygen therapy system, also called the THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) system, appears to provide better patient safety than conventional techniques. Panendoscopy is a very common diagnostic procedure in ENT surgery. The general anesthesia during the diagnostic panendoscopy is a good representation of the induction stage. Indeed, the procedure of preoxygenation preceding anesthetic induction and direct laryngoscopy corresponds to the airway management that is an integral part of each general anesthesia. This is why researchers are studying it in particular to improve patient safety during difficult intubations. The paradox is that there is no consensus on the anesthetic strategy for this procedure that counts four main methods for the airway management of patients requiring an ENT panendoscopy. In our center, the investigators use, in most situations, a variant of spontaneous ventilation described by Y. Jacquet et al., with the difference that the investigators use a transglottic oxygenation probe during the procedure. During laryngoscopy, the operator positions a naso-tracheal tube after local anesthesia of the vocal cords. The oxygen flow is reduced to 3 L/min before the exploration procedure. The arrival in operating theaters of the Optiflow™ system, developed by the New Zealand Company Fisher \& Paykel Healthcare, has led to a rethinking of the way oxygen is delivered. This device allows the administration of a flow rate of up to 70 L/min while delivering heated gases.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of arterial desaturation

  The O2 saturation defined as SpO2 \<95% will be collected each time it reaches 94% or less

  1 day, during the procédure

Secondary Outcomes (10)

• Measure the non-hypoxemic apnea time

  1 day, during the procédure

• Incidence of the use of manual ventilation

  1 day, during the procedure

• Incidence of the use of tracheal intubation

  1 day, during the procedure

• Incidence of the use of neuromuscular blocking drugs

  1 day, during the procedure

• Incidence of emergency tracheostomy

  1 day, during the procedure

Study Arms (2)

Arm A: investigational device (Respiratory Gas Delivery System)

EXPERIMENTAL

Patients ventilated with the Optiflow™ system, a nasal high flow oxygenation system (NHFO) while undergoing a panendoscopy

Procedure: Respiratory Gas Delivery System

Arm B: standard nasal oxygenation device

ACTIVE COMPARATOR

Patients ventilated according to the standard technique while undergoing a panendoscopy

Procedure: Respiratory Gas Delivery System

Interventions

Respiratory Gas Delivery System PROCEDURE

Oxygen therapy during general anesthesia for ENT panendoscopy

Arm A: investigational device (Respiratory Gas Delivery System); Arm B: standard nasal oxygenation device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from a head and neck cancer, most often tumor of the bucco-pharyngo-laryngeal cavities, having to carry out a diagnostic HN panendoscopy;
• Patient over 18 years of age;
• ASA \< 4;
• BMI ≤ 45;
• Patient willing and able to provide written informed consent for the trial;;
• Patient affiliated with a health insurance system.

You may not qualify if:

• Patient with a contraindication to the Optiflow™ system as defined in the manufacturer's brochure;
• Patient with a tumor obstructing more than 80% of the glottic lumen;
• Patient with impossible intubation criteria:
• Mallampati 4 and mouth opening less than 20 mm
• Retrognathia
• Patient with:
• A known intracranial pathology;
• Documented pulmonary hypertension;
• Uncontrolled epilepsy;
• Uncontrolled heart rhythm disorder;
• Pulmonary pathology with hypoxemia: Spo2 \<92% in ambient air;
• Patient at high risk of a full stomach evaluated by the anesthetist;
• ASA ≥ 4
• Morbid obesity with BMI\> 45;
• Obstructive upper airway tumor with functional impact;

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Pierre-Henri KOULMANN, MD

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: To compare the incidence of oxygen desaturation in patients ventilated with the Optiflow™ system to that of patients treated according to the standard technique.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 25, 2023
• Study Start: April 12, 2023
• Primary Completion: May 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)