Prevention of Sleep Apnea After General Anaesthesia With a MAD

Sleep Apnea Clinical Trial

— PoMAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731168
• Other study ID #: 2020-01177
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Peri-operative Medicine
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Mandibular advancement device
Patients will have a mandibular advancement device during the first postoperative night

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supine AHI	Apnea-Hypopnea index in the supine position	Postoperative night 1
Secondary	Global AHI	Gobal Apnea-Hypopnea index: the number of apnoea and hypopnoea per hour of recording	Postoperative night 1
Secondary	OAI	Obstructive apnoea index: the number of apnoea from an obstructive origin per hour of recording	Postoperative night 1
Secondary	CAI	Central apnoea index: the number of apnoea from a central origin per hour of recording	Postoperative night 1
Secondary	Hypopnea index	Hypopnea index: the number of hypopnoea per hour of recording	Postoperative night 1
Secondary	ODI	Obstruction desaturation index: number of oxygen desaturation (=3%) episodes per hour of sleep.	Postoperative night 1
Secondary	Respiratory Rate	Respiratory Rate	Postoperative night 1
Secondary	Percentage of supine time	Percentage of supine time	Postoperative night 1