OPTIGO /Comparison of Two Ventilation Methods During Endoscopy of the Pharynx, Larynx and Oesophagus: Multicentre, Randomised, Non-inferiority Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Poitiers
RECRUITING
Poitiers
Contact Information
Primary
Guillaume BEAUMATIN
guillaume.beaumatin@chu-poitiers.fr
+33549443652
Backup
Rémi DRILLEAU
remi.drilleau@chu-poitiers.fr
+33549446049
Time Frame
Start Date: 2025-07-11
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 610
Treatments
Active_comparator: Laryngoscopy
Experimental: High-flow oxygen therapy
Related Therapeutic Areas
Sponsors
Leads: Poitiers University Hospital

This content was sourced from clinicaltrials.gov