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OpenTrials
Completed

NCT Number: NCT04731168

Prevention of Sleep Apnea After General Anaesthesia With a MAD

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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Key information

Conditions

Peri-operative Medicine Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular advancement device

Device

Patients will have a mandibular advancement device during the first postoperative night

Primary outcomes

  1. Supine AHI

    Time frame: Postoperative night 1

    Apnea-Hypopnea index in the supine position

Secondary outcomes

  1. Global AHI

    Time frame: Postoperative night 1

    Gobal Apnea-Hypopnea index: the number of apnoea and hypopnoea per hour of recording

  2. OAI

    Time frame: Postoperative night 1

    Obstructive apnoea index: the number of apnoea from an obstructive origin per hour of recording

  3. CAI

    Time frame: Postoperative night 1

    Central apnoea index: the number of apnoea from a central origin per hour of recording

  4. Hypopnea index

    Time frame: Postoperative night 1

    Hypopnea index: the number of hypopnoea per hour of recording

  5. ODI

    Time frame: Postoperative night 1

    Obstruction desaturation index: number of oxygen desaturation (≥3%) episodes per hour of sleep.

  6. Respiratory Rate

    Time frame: Postoperative night 1

    Respiratory Rate

  7. Percentage of supine time

    Time frame: Postoperative night 1

    Percentage of supine time

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: PoMAD

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2021
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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