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

NCT07004699 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2026-02-27

No results posted yet for this 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. They are performed in most cases as part of a swelling assessment, following CT scans, or following the discovery of a mass upon palpation of the patient. Unfortunately, these are aggressive cancers that subsequently require major surgery and additional treatment by radio or chemotherapy. This examination can also be performed on patients suffering from swallowing disorders, following the appearance of polyps, and this time not requiring an adjuvant to surgery but their removal. 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. The evaluation of this benefit compared to the standard method will be done using several elements including the collection of continuous saturation and blood analysis of capillary samples pre-, per- and post-operatively.

Conditions

  • Oxygen Inhalation Therapy Endoscopy

Interventions

PROCEDURE

Laryngoscopy

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

PROCEDURE

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.

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Guillaume BEAUMATIN · Poitiers University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07004699 on ClinicalTrials.gov