About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Laryngoscopy
Procedure/SurgeryIntroduction of the laryngoscope to maintain spontaneous ventilation in order to observe, in real conditions, the evolution and movements of the otorhinolaryngology sphere.
High-flow oxygen therapy
Procedure/SurgeryIntroduction of High-flow oxygen therapy to maintain spontaneous ventilation in order to observe, in real conditions, the evolution and movements of the otorhinolaryngology sphere.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with intraoperative oxygen desaturation
Oxygen desaturation is defined as the onset of an episode of SpO2 ≤ 85% during the surgery
Secondary outcomes
Proportion of patients with intraoperative complications
Presence of bleeding from mouth and pharynx and rupture of teeth related to laryngoscopy
Postoperative laryngeal pain
Laryngeal pain will be assessed using a numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Comfort of the surgeon during the surgery
Comfort will be assessed with a numerical rating scale ranging from 0 (very uncomfortable) to 10 (very comfortable)
Duration of the surgical procedure
Time will be measured from the suspension laryngoscopy to the end of the procedure (expressed in minutes)
Sponsors and contacts
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