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Recruiting Not applicable

Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus

NCT07004699 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-07-11
Last updated
2026-08-31

Condition(s) studied

Oxygen Inhalation Therapy Endoscopy

Investigational drug(s) / intervention(s)

LaryngoscopyHigh-flow oxygen therapy

Laryngoscopy: Introduction of the laryngoscope to maintain spontaneous ventilation in order to observe, in real conditions, the evolution and movements of the otorhinolaryngology sphere.

High-flow oxygen therapy: Introduction of High-flow oxygen therapy to maintain spontaneous ventilation in order to observe, in real conditions, the evolution and movements of the otorhinolaryngology sphere.

Study summary

Around 15,000 ENT cancers are diagnosed each year in France. The majority of these cancers will at one time or another require an Endoscopy of the Pharynx, Larynx and Esophagus (Endo-PLE or suspension laryngoscopy). Endoscopies of the Otorhinolaryngeal (ENT) sphere are common procedures. They consist of inserting a rigid laryngoscope through the mouth, allowing full exposure of the laryngeal sphere. For all patients, these endo-PLE are performed in the operating room and require general anesthesia. This surgical procedure is now performed by performing two laryngoscopies. The first is used to maintain good pulmonary oxygenation by introducing an oxygen cannula, the second constitutes the surgical procedure itself. The oxygen cannula is placed through the nasal cavity, directly up to the entrance of the vocal cords. This procedure is not without risk both for the patient (risk of dental breakage and bleeding during laryngoscopy) but also for the surgeon, because the cannula itself can obstruct his vision. It would be possible to do without one of them by setting up high-flow oxygen therapy (HFOT). This device has been widely deployed in continuous care and intensive care units, but is not yet the subject of much research in surgical units. The HFOT consists of oxygen cannulae delivering a mixture of gases at a high flow rate ranging from 20 to 70 liters per minute. The investigator want to evaluate through this study, the feasibility and effectiveness of setting up HFOT during procedures.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient aged 18 or over. * Scheduled for upper aerodigestive tract endoscopy (pharynx, larynx, oesophagus). * ASA physical status I to IV. * No requirment for preoperative supplemental oxygen. * Informed consent signed. Exclusion Criteria: * Endoscopy combined with another procedure. * Body mass index ≥ 35 kg/m². * Severe chronic obstructive pulmonary disease (GOLD stage IV). * Allergy to one of the anaesthetic agents (remifentanil, propofol, lidocaine). * Baseline SpO2 ≤ 92% on arrival in the operating room

Primary outcome measure(s)

  • Proportion of patients with intraoperative oxygen desaturation — During the surgical procedure
    Oxygen desaturation is defined as the onset of an episode of SpO2 ≤ 85% during the surgery

Trial sites (3)

FacilityCityRegionStatus
CHD Vendée La Roche-sur-Yon France Recruiting
CHU Limoges Limoges France Recruiting
CHU Poitiers Poitiers France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07004699 on ClinicalTrials.gov ↗ ← All trials in France