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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea; Peri-operative Medicine
• Intervention / Treatment: Device: Mandibular advancement device

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois and University of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: MAD; Patients will have a mandibular advancement device during the first postoperative night	Device: Mandibular advancement device; Patients will have a mandibular advancement device during the first postoperative night

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 2020-01177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No