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.

NCT ID: NCT04345354

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-14

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Abdominal Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with continuous positive airway pressure treatment

No interventions assigned to this group

without continuous positive airway pressure treatment

No interventions assigned to this group

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Claude MEURICE

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

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Chu de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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APNOSIS-BIS

Identifier Type: -

Identifier Source: org_study_id

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