Peri-operative Medicine, Sleep Apnea
Conditions
Brief 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.
Interventions
DEVICEMandibular advancement device
Patients will have a mandibular advancement device during the first postoperative night
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Supine AHI | Postoperative night 1 | Apnea-Hypopnea index in the supine position |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OAI | Postoperative night 1 | Obstructive apnoea index: the number of apnoea from an obstructive origin per hour of recording |
| CAI | Postoperative night 1 | Central apnoea index: the number of apnoea from a central origin per hour of recording |
| Hypopnea index | Postoperative night 1 | Hypopnea index: the number of hypopnoea per hour of recording |
| Global AHI | Postoperative night 1 | Gobal Apnea-Hypopnea index: the number of apnoea and hypopnoea per hour of recording |
| Respiratory Rate | Postoperative night 1 | Respiratory Rate |
| Percentage of supine time | Postoperative night 1 | Percentage of supine time |
| ODI | Postoperative night 1 | Obstruction desaturation index: number of oxygen desaturation (≥3%) episodes per hour of sleep. |
Countries
Switzerland
Outcome results
None listed