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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345354
Other study ID # APNOSIS-BIS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 14, 2016
Est. completion date December 2018

Study information

Verified date April 2020
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Chu de Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment 7 days
Primary Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment 7 days
Primary Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment 7 days
Primary Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment 7 days
Secondary Evaluate tolerance and observance of continuous positive airway pressure treatment 7 days
Secondary Evaluate the feasibility of the ApneaLink 7 days
Secondary Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score, 7 days
Secondary Evaluate the duration and place of hospitalization during the post-surgical course 28 days
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