Prevention of Sleep Apnea After General Anaesthesia With a MAD

Not Applicable

Completed

• Conditions: Peri-operative Medicine; Sleep Apnea
• Interventions: Device: Mandibular advancement device

• Registration Number: NCT04731168
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-02-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAD	Mandibular advancement device	Patients will have a mandibular advancement device during the first postoperative night

Primary Outcome Measures

Name	Time	Method
Supine AHI	Postoperative night 1	Apnea-Hypopnea index in the supine position

Secondary Outcome Measures

Name	Time	Method
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
ODI	Postoperative night 1	Obstruction desaturation index: number of oxygen desaturation (≥3%) episodes per hour of sleep.
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois and University of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland