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

Vaud University Hospital Center

Status

Completed

Conditions

Peri-operative Medicine

Sleep Apnea

Treatments

Device: Mandibular advancement device

Study type

Interventional

Funder types

Other

Identifiers

NCT04731168

2020-01177

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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