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

July 12, 2016 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in heart rhythm troubles linked to hypoxemia events
Time Frame: 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
Before surgery and at first and third night after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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
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
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
Before surgery and at first and third night after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

AGIR à Dom

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

July 12, 2016

First Posted (ESTIMATE)

July 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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