Skip to main content
OpenTrials
Completed

NCT Number: NCT04345354

Observational Study of the Value of Using Obstructive Sleep Apnea-hypopnea Syndrome (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.

The presence of an obstructive sleep apnea-hypopnea syndrome (OSAHS) is a perfectly identified cardiovascular and metabolic risk factor responsible for excess mortality in patients with severe OSAHS, while life expectancy, when the SAHOS is treated by continuous positive airway pressure (CPAP) is close to that of the general population. It also represents a factor of excess mortality, little known and poorly explored, in relation to morbidity and mortality occurring during the perioperative period accompanying any general anesthesia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Abdominal Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Poitiers

Poitiers, 86021, France

Who can participate

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

Inclusion criteria

  • Patients over 18 years old and naive to any treatment with obstructive sleep apnea-hypopnea syndrome,
  • Patients at high risk of obstructive sleep apnea-hypopnea syndrome (STOP BANG ≥ 3),
  • Patients scheduled for major abdominal surgery (all intraperitoneal surgeries excluding vesicles, eventrations and hernias, all aortic surgeries excluding endovascular surgeries) within a minimum of 10 days,
  • It is possible to integrate the explanations concerning the realization of the ApneaLink ™ Air in autonomy and to ensure its restitution under 24-48h,

Exclusion criteria

  • Patients with obstructive sleep apnea-hypopnea syndrome diagnosed before surgery,
  • Patients with heart failure (NYHA> II),
  • Patients with moderate to severe COPD
  • Patients participating in a clinical trial,

Treatment and study plan

Primary outcomes

  1. Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment

    Time frame: 7 days

  2. Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment

    Time frame: 7 days

  3. Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment

    Time frame: 7 days

  4. Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment

    Time frame: 7 days

Secondary outcomes

  1. Evaluate tolerance and observance of continuous positive airway pressure treatment

    Time frame: 7 days

  2. Evaluate the feasibility of the ApneaLink

    Time frame: 7 days

  3. Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,

    Time frame: 7 days

  4. Evaluate the duration and place of hospitalization during the post-surgical course

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Observational Study of the Value of Using Continuous Positive Airway Pressure (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.

Acronym: APNOSIS-BIS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2020
Registry last updated
Apr 14, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.