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Etude3A: Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Unknown status
CT.gov ID
NCT02833662
Collaborator
AGIR à Dom (Other)
120
Enrollment
1
Arm
25
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Measure of ODI and heart rhythm
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evolution of the Severity of Obstructive Sleep Apnea and Consequences on Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Patients suspected to present a Sleep Apnea Syndrom

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.

Other: Measure of ODI and heart rhythm
Record nocturnal respiratory and cardiac parameters before and after surgery.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in heart rhythm troubles linked to hypoxemia events [Before surgery and at first and third night after surgery]

    Heart 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 Outcome Measures

  1. Change from baseline in severity of OSA defined by the oxygen saturation index [Before surgery and at first and third night after surgery]

    OSA 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

  2. Aggravation of cardiac events linked to hypoxemia [After surgery from night 1 to night 15 maximum]

  3. Change from baseline OSA prevalence and cardiorespiratory complications after surgery [Before surgery and at first and third night after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 99 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Grenoble
  • AGIR à Dom

Investigators

  • Principal Investigator: Renaud TAMISIER, Md,PhD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT02833662
Other Study ID Numbers:
  • 38RC15.080
First Posted:
Jul 14, 2016
Last Update Posted:
Jul 14, 2016
Last Verified:
May 1, 2016
Keywords provided by University Hospital, Grenoble
Hypoxia
Perioperative outcomes
Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive

Study Results

No Results Posted as of Jul 14, 2016