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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| MAD | Experimental | Patients will have a mandibular advancement device during the first postoperative night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular advancement device | Device | Patients will have a mandibular advancement device during the first postoperative night |
|
| Measure | Description | Time Frame |
|---|---|---|
| Supine AHI | Apnea-Hypopnea index in the supine position | Postoperative night 1 |
| 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 |
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Inclusion Criteria:
- adult patient undergoing any lower limb surgery
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois and University of Lausanne | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| 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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |