Prevention of Sleep Apnea After General Anaesthesia With a MAD
NCT04731168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-11-21
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
- DEVICE
-
Mandibular advancement device
Patients will have a mandibular advancement device during the first postoperative night
Sponsors & Collaborators
-
Centre Hospitalier Universitaire Vaudois
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-01
- Primary Completion
- 2023-10-31
- Completion
- 2023-10-31
Countries
- Switzerland
Study Locations
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