Prevention of Sleep Apnea After General Anaesthesia With a MAD (PoMAD)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    100
  • sponsor
    Centre Hospitalier Universitaire Vaudois
Updated on 20 April 2022
oximetry
mandibular advancement

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.

Details
Condition Peri-operative Medicine, Sleep Apnea
Treatment Mandibular advancement device
Clinical Study IdentifierNCT04731168
SponsorCentre Hospitalier Universitaire Vaudois
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

adult patient undergoing any lower limb surgery

Exclusion Criteria

continuous positive airway pressure (CPAP) treatment for obstructive sleep apnoea
presence of severe respiratory or cardiovascular disease
preoperative consumption of benzodiazepine
chronic use of opioids > 30 mg/day morphine equivalent
no tooth
patient known for malignant hyperthermia
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