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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Laryngoscopy

    Procedure/Surgery

    Introduction 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/Surgery

    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.

Treatment groups

610 Participants
are divided into 2 treatment groups
Group A: LaryngoscopyActive comparator 1 intervention
Group B: High-flow nasal oxygen therapyExperimental treatment 1 intervention

Trial outcomes

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

Time frame
During the surgical procedure

Secondary outcomes

1

Proportion of patients with intraoperative complications

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

Time frame
During the surgical procedure
2

Postoperative laryngeal pain

Laryngeal pain will be assessed using a numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)

Time frame
When leaving the Post Interventional Monitoring Room
3

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)

Time frame
At the end of the surgical procedure
4

Duration of the surgical procedure

Time will be measured from the suspension laryngoscopy to the end of the procedure (expressed in minutes)

Time frame
At the end of the surgical procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.