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Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia

Evolution of the Severity of Obstructive Sleep Apnea and Consequences on Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02833662
Acronym
Etude3A
Enrollment
120
Registered
2016-07-14
Start date
2015-06-30
Completion date
2017-07-31
Last updated
2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Obstructive Sleep Apnea

Keywords

Hypoxia, Perioperative outcomes

Brief 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.

Interventions

OTHERMeasure of ODI and heart rhythm

Record nocturnal respiratory and cardiac parameters before and after surgery.

Sponsors

AGIR à Dom
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in heart rhythm troubles linked to hypoxemia eventsBefore surgery and at first and third night after surgeryHeart rhythm troubles will be assessed 3 times: * First time = baseline assessment, during one night before surgery * second assessment will occur during the first night after surgery * last assessment will take place during the third night after surgery

Secondary

MeasureTime frameDescription
Change from baseline in severity of OSA defined by the oxygen saturation indexBefore surgery and at first and third night after surgeryOSA will be assessed 3 times: * First time = baseline assessment, during one night before surgery * second assessment will occur during the first night after surgery * last assessment will take place during the third night after surgery oxygen saturation index \> 10 mandatory for the study oxygen saturation index \> 40 : result qualified severe
Aggravation of cardiac events linked to hypoxemiaAfter surgery from night 1 to night 15 maximum
Change from baseline OSA prevalence and cardiorespiratory complications after surgeryBefore surgery and at first and third night after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026