Prevention of Sleep Apnea After General Anaesthesia With a MAD

Study Overview
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Brief Summary
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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.

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

Conditions
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Peri-operative Medicine, Sleep Apnea

Intervention / Treatment
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* Device: Mandibular advancement device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: MAD<br>Patients will have a mandibular advancement device during the first postoperative night | Device: Mandibular advancement device<br>* Patients will have a mandibular advancement device during the first postoperative night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supine AHI | Apnea-Hypopnea index in the supine position | Postoperative night 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global AHI | Gobal Apnea-Hypopnea index: the number of apnoea and hypopnoea per hour of recording | Postoperative night 1 | 
| OAI | Obstructive apnoea index: the number of apnoea from an obstructive origin per hour of recording | Postoperative night 1 | 
| CAI | Central apnoea index: the number of apnoea from a central origin per hour of recording | Postoperative night 1 | 
| Hypopnea index | Hypopnea index: the number of hypopnoea per hour of recording | Postoperative night 1 | 
| ODI | Obstruction desaturation index: number of oxygen desaturation (≥3%) episodes per hour of sleep. | Postoperative night 1 | 
| Respiratory Rate | Respiratory Rate | Postoperative night 1 | 
| Percentage of supine time | Percentage of supine time | Postoperative night 1 |