NCT07004699 Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus
| NCT ID | NCT07004699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poitiers University Hospital |
| Condition | Oxygen Inhalation Therapy Endoscopy |
| Study Type | INTERVENTIONAL |
| Enrollment | 610 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 610 participants in total. It began in 2025-07-11 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Guillaume BEAUMATIN
STUDY DIRECTOR
Poitiers University Hospital
Frequently Asked Questions
Who can join the NCT07004699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oxygen Inhalation Therapy Endoscopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07004699 currently recruiting?
Yes, NCT07004699 is actively recruiting participants. Contact the research team at guillaume.beaumatin@chu-poitiers.fr for enrollment information.
Where is the NCT07004699 trial being conducted?
This trial is being conducted at La Roche-sur-Yon, France, Limoges, France, Poitiers, France.
Who is sponsoring the NCT07004699 clinical trial?
NCT07004699 is sponsored by Poitiers University Hospital. The principal investigator is Guillaume BEAUMATIN at Poitiers University Hospital. The trial plans to enroll 610 participants.