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. (APNOSIS-BIS)

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.

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.

Study Overview

• Status: Completed
• Conditions: Major Abdominal Surgery

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • CHU de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients without known obstructive sleep apnea-hypopnea syndrome, presenting at anesthesia consultation for visceral surgery to be performed at least within 10 days.

Description

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,

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patient with continuous positive airway pressure treatment
without continuous positive airway pressure treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment	7 days
Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment	7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment	7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate tolerance and observance of continuous positive airway pressure treatment	7 days
Evaluate the feasibility of the ApneaLink	7 days
Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,	7 days
Evaluate the duration and place of hospitalization during the post-surgical course	28 days

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Jean-Claude MEURICE, Poitiers university hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: APNOSIS-BIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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