RecruitingNot ApplicableNCT07004699

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

OPTIGO /Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus: Multicentre, Randomised, Non-inferiority Trial


Sponsor

Poitiers University Hospital

Enrollment

610 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called High-flow oxygen therapy and a procedure called Laryngoscopy for people with oxygen inhalation therapy endoscopy. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaryngoscopy

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

PROCEDUREHigh-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.


Locations(3)

CHD Vendée

La Roche-sur-Yon, France

CHU Limoges

Limoges, France

CHU Poitiers

Poitiers, France

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NCT07004699