NCT04731168

Prevention of Sleep Apnea After General Anaesthesia With a MAD

Prevention of Sleep Apnea After General Anaesthesia With a Mandibular Advancement Device: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sleep apneic episodes increase after general anaesthesia up to the third postoperative night. A mandibular advancement device, called MAD, is a small device that is inserted in the patient's mouth during the night and allows the advancement of the mandible, preventing sleep apneic episodes. The objective of this randomized controlled trial is to determine whether a MAD reduces the impact of general anaesthesia on the increase of the sleep apneic episodes in the postoperative period. All patients will have their sleep-related respiratory data measured using a portable respiratory polygraphy recorder (ResMed Embletta® system). This portable recorder allows a non-invasive recording of nasal airflow through a nasal cannula, oxygen saturation (SpO2) via finger pulse oximetry, respiratory efforts through thoracic and abdominal belts, and body position.

Conditions

• Peri-operative Medicine
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Mandibular advancement device	Patients will have a mandibular advancement device during the first postoperative night

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2021-01-29
• Last updated: 2023-11-21

Locations

1 site across 1 country: Switzerland