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

NCT07004699 | Recruiting

• 1 other identifier: OPTIGO
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• The presence of oxygen desaturation ≤ 85% (Pulse Oxygen Saturation ) of the patient ≤ 85%.

  during the surgery

  up to 24 hours

Secondary Outcomes (7)

• Level of oxygenation

  up to 24 hours

• Presence of bleeding from mouth and pharynx and rupture of teeth related to laryngoscopy

  up to 24 hours

• Patient pain assessed

  up to 24 hours

• The surgeon's comfort during the operation

  up to 24 hours

• The duration in minutes of the suspension laryngoscopy performed by the surgeon until the end of the surgical procedure

  up to 24 hours

Study Arms (2)

Laryngoscopy

ACTIVE COMPARATOR

Procedure: Laryngoscopy

High-flow oxygen therapy

EXPERIMENTAL

Procedure: High-flow oxygen therapy

Interventions

Laryngoscopy PROCEDURE

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

Laryngoscopy

High-flow oxygen therapy PROCEDURE

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.

High-flow oxygen therapy

Eligibility Criteria

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

You may qualify if:

• Patient aged 18 or over.
• Not requiring oxygen.
• About to undergo exclusive Endoscopy of the pharynx, larynx and oesophagus surgery.
• Score de l'American Society of Anesthesiology between 1 and 4
• Informed consent signed

You may not qualify if:

• Endoscopy of the pharynx, larynx and oesophagus surgery combined with another procedure
• Severe or morbid obesity (BMI ≥ 35 kg/m²)
• Patients with stage IV chronic obstructive pulmonary disease
• Allergy to one of the drugs used in anaesthesia, remifentanil and/or propofol and/or lidocaine.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (2)

CHU Poitiers

Poitiers, 86000, France

RECRUITING

CHU de Poitiers

Poitiers, 86021, France

NOT YET RECRUITING

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Guillaume BEAUMATIN

  Poitiers University Hospital

  STUDY DIRECTOR

Central Study Contacts

Guillaume BEAUMATIN

CONTACT

+33549443652; guillaume.beaumatin@chu-poitiers.fr

Rémi DRILLEAU

CONTACT

+33549446049; remi.drilleau@chu-poitiers.fr

Study Design

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

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: June 4, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It will be accessible two years after the end of the study and will remain so for a period of 15 years.
• Access Criteria: The study dataset is the property of the sponsor (Poitiers University Hopsital, France) and will be made available to the steering committee and participating investigators. In agreement with European and French law, pseudonymised data cannot be open. For data sharing, a request can be performed to the principal investigator (corresponding author). Data transfert agreement can be proposed after the agreement of the steering committee of the study and the completion of collaborative forms with the sponsor.

Locations

FR (2)