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: 3

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. 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.

Conditions

Oxygen Inhalation Therapy Endoscopy

Keywords

high-flow nasal oxygen; upper aerodigestive tract endoscopy; pain

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with intraoperative oxygen desaturation

  Oxygen desaturation is defined as the onset of an episode of SpO2 ≤ 85% during the surgery

  During the surgical procedure

Secondary Outcomes (7)

• Proportion of patients with intraoperative complications

  During the surgical procedure

• Postoperative laryngeal pain

  When leaving the Post Interventional Monitoring Room

• Comfort of the surgeon during the surgery

  At the end of the surgical procedure

• Duration of the surgical procedure

  At the end of the surgical procedure

• Duration of anaesthesia

  At the end of the surgical procedure

Study Arms (2)

Laryngoscopy

ACTIVE COMPARATOR

Standard oxygenation using a nasopharyngeal oxygen catheter

Procedure: Laryngoscopy

High-flow nasal oxygen therapy

EXPERIMENTAL

Oxygen delivered via heated and humidified high-flow nasal cannula

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 nasal 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.
• Scheduled for upper aerodigestive tract endoscopy (pharynx, larynx, oesophagus).
• ASA physical status I to IV.
• No requirment for preoperative supplemental oxygen.
• Informed consent signed.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (3)

CHD Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

CHU Limoges

Limoges, 87000, France

RECRUITING

CHU Poitiers

Poitiers, 86000, France

RECRUITING

Related Publications (1)

• Alleyrat C, Drilleau R, Brasseur JM, Karayan J, Saenz-Molina C, Frasca D, Boisson M, Beaumatin G. High-flow nasal oxygen versus nasopharyngeal oxygen insufflation during upper aerodigestive tract endoscopy: protocol for a multicentre randomised controlled non-inferiority trial (OPTIGO). BMJ Open. 2026 Jun 1;16(6):e112540. doi: 10.1136/bmjopen-2025-112540.

  PMID: 42225363 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)