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

Primary Purpose

Peri-operative Medicine, Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mandibular advancement device
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peri-operative Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois and University of LausanneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

MAD

Arm Description

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

Outcomes

Primary Outcome Measures

Supine AHI
Apnea-Hypopnea index in the supine position

Secondary Outcome Measures

Global AHI
Gobal Apnea-Hypopnea index: the number of apnoea and hypopnoea per hour of recording
OAI
Obstructive apnoea index: the number of apnoea from an obstructive origin per hour of recording
CAI
Central apnoea index: the number of apnoea from a central origin per hour of recording
Hypopnea index
Hypopnea index: the number of hypopnoea per hour of recording
ODI
Obstruction desaturation index: number of oxygen desaturation (≥3%) episodes per hour of sleep.
Respiratory Rate
Respiratory Rate
Percentage of supine time
Percentage of supine time

Full Information

First Posted
January 25, 2021
Last Updated
March 30, 2022
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT04731168
Brief Title
Prevention of Sleep Apnea After General Anaesthesia With a MAD
Acronym
PoMAD
Official Title
Prevention of Sleep Apnea After General Anaesthesia With a Mandibular Advancement Device: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-operative Medicine, Sleep Apnea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
MAD
Arm Type
Experimental
Arm Description
Patients will have a mandibular advancement device during the first postoperative night
Intervention Type
Device
Intervention Name(s)
Mandibular advancement device
Intervention Description
Patients will have a mandibular advancement device during the first postoperative night
Primary Outcome Measure Information:
Title
Supine AHI
Description
Apnea-Hypopnea index in the supine position
Time Frame
Postoperative night 1
Secondary Outcome Measure Information:
Title
Global AHI
Description
Gobal Apnea-Hypopnea index: the number of apnoea and hypopnoea per hour of recording
Time Frame
Postoperative night 1
Title
OAI
Description
Obstructive apnoea index: the number of apnoea from an obstructive origin per hour of recording
Time Frame
Postoperative night 1
Title
CAI
Description
Central apnoea index: the number of apnoea from a central origin per hour of recording
Time Frame
Postoperative night 1
Title
Hypopnea index
Description
Hypopnea index: the number of hypopnoea per hour of recording
Time Frame
Postoperative night 1
Title
ODI
Description
Obstruction desaturation index: number of oxygen desaturation (≥3%) episodes per hour of sleep.
Time Frame
Postoperative night 1
Title
Respiratory Rate
Description
Respiratory Rate
Time Frame
Postoperative night 1
Title
Percentage of supine time
Description
Percentage of supine time
Time Frame
Postoperative night 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois and University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, PD Dr
Phone
+41795566341
Email
eric.albrecht@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prevention of Sleep Apnea After General Anaesthesia With a MAD

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