Overview

This trial is active, not recruiting.

Conditions obstructive sleep apnea, arrhythmia
Treatment measure of odi and heart rhythm
Sponsor University Hospital, Grenoble
Collaborator AGIR à Dom
Start date June 2015
End date December 2016
Trial size 120 participants
Trial identifier NCT02833662, 38RC15.080

Summary

Higher risk of cardiac and respiratory post-operative events is observed in patients with unrecognised Obstructive Sleep Apnea (OSA). The efficiency of a simple method of OSA screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia (oxygen desaturation index) will be assessed. These sleep respiratory analyses will be compared with the research of arrhythmia, in order to show if they are linked to the hypoxemia events.

Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory postoperative complications will be assessed in OSA patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Other)
Record nocturnal respiratory and cardiac parameters before and after surgery : Severity of sleep respiratory disorders and relationship with cardiac rhythm abnormalities will be assessed in patients suspected to present Sleep Apnea, before and after surgery under general anesthesia.
measure of odi and heart rhythm
Record nocturnal respiratory and cardiac parameters before and after surgery.

Primary Outcomes

Measure
Change from baseline in heart rhythm troubles linked to hypoxemia events
time frame: Before surgery and at first and third night after surgery

Secondary Outcomes

Measure
Change from baseline in severity of OSA defined by the oxygen saturation index
time frame: Before surgery and at first and third night after surgery
Aggravation of cardiac events linked to hypoxemia
time frame: After surgery from night 1 to night 15 maximum
Change from baseline OSA prevalence and cardiorespiratory complications after surgery
time frame: Before surgery and at first and third night after surgery

Eligibility Criteria

Male or female participants from 45 years up to 99 years old.

Inclusion Criteria: - orthopaedic, urologic, vascular, digestive surgery - under general anaesthesia or sedation - age > 45 years old - STOP-BANG score>3 Exclusion Criteria: - Head and neck surgery, planned prolonged mechanical ventilation after surgery (>24h) - Severe COPD - Post-operative ICU planned - Diagnosed OSA or other sleep disorder breathing

Additional Information

Official title Evolution of the Severity of Obstructive Sleep Apnea and Consequences on Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia
Principal investigator Renaud TAMISIER, Md,PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Grenoble.