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Obstructive Sleep ApneaEtude3ANCT02833662

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

A study testing Measure of ODI and heart rhythm in people with Obstructive Sleep Apnea and Arrhythmia, run by University Hospital, Grenoble.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Obstructive Sleep Apnea, Arrhythmia
What is being tested?
Measure of ODI and heart rhythm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Jun 2015to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • orthopaedic, urologic, vascular, digestive surgery
  • under general anaesthesia or sedation
  • age > 45 years old
  • STOP-BANG score>3

Who cannot join

  • Head and neck surgery, planned prolonged mechanical ventilation after surgery (>24h)
  • Severe COPD
  • Post-operative ICU planned
  • Diagnosed OSA or other sleep disorder breathing

About this study

Official title: 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.

Being tested
Measure of ODI and heart rhythm
Keywords
Hypoxia, Perioperative outcomes
Medical subject headings
Sleep Apnea, Obstructive, Arrhythmias, Cardiac, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measure of ODI and heart rhythmOther

    Record nocturnal respiratory and cardiac parameters before and after surgery.

Study groups in NCT02833662
Study groupRoleWhat they receive
Patients suspected to present a Sleep Apnea SyndromOtherRecord 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.
Receives: Other: Measure of ODI and heart rhythm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in heart rhythm troubles linked to hypoxemia events

    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

    Measured: Before surgery and at first and third night after surgery

Secondary outcomes (3)

  1. Change from baseline in severity of OSA defined by the oxygen saturation index

    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

    Measured: Before surgery and at first and third night after surgery

  2. Aggravation of cardiac events linked to hypoxemia

    Measured: After surgery from night 1 to night 15 maximum

  3. Change from baseline OSA prevalence and cardiorespiratory complications after surgery

    Measured: Before surgery and at first and third night after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02833662
Sponsor's protocol ID
38RC15.080
Acronym
Etude3A
Status last verified
May 2016
First submitted
3 Jun 2015
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Chung F, Liao P, Yegneswaran B, Shapiro CM, Kang W. Postoperative changes in sleep-disordered breathing and sleep architecture in patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):287-98. doi: 10.1097/ALN.0000000000000040.

    PubMed 24158049

  • Kaw R, Chung F, Pasupuleti V, Mehta J, Gay PC, Hernandez AV. Meta-analysis of the association between obstructive sleep apnoea and postoperative outcome. Br J Anaesth. 2012 Dec;109(6):897-906. doi: 10.1093/bja/aes308. Epub 2012 Sep 6.

    PubMed 22956642

  • Vizzardi E, Sciatti E, Bonadei I, D'Aloia A, Curnis A, Metra M. Obstructive sleep apnoea-hypopnoea and arrhythmias: new updates. J Cardiovasc Med (Hagerstown). 2017 Jul;18(7):490-500. doi: 10.2459/JCM.0000000000000043.

    PubMed 25000252

  • Kilicaslan F, Tokatli A, Ozdag F, Uzun M, Uz O, Isilak Z, Yiginer O, Yalcin M, Guney MS, Cebeci BS. Tp-e interval, Tp-e/QT ratio, and Tp-e/QTc ratio are prolonged in patients with moderate and severe obstructive sleep apnea. Pacing Clin Electrophysiol. 2012 Aug;35(8):966-72. doi: 10.1111/j.1540-8159.2012.03439.x. Epub 2012 Jun 5.

    PubMed 22671991

  • Chung F, Liao P, Elsaid H, Shapiro CM, Kang W. Factors associated with postoperative exacerbation of sleep-disordered breathing. Anesthesiology. 2014 Feb;120(2):299-311. doi: 10.1097/ALN.0000000000000041.

    PubMed 24158050

  • Singh M, Liao P, Kobah S, Wijeysundera DN, Shapiro C, Chung F. Proportion of surgical patients with undiagnosed obstructive sleep apnoea. Br J Anaesth. 2013 Apr;110(4):629-36. doi: 10.1093/bja/aes465. Epub 2012 Dec 19.

    PubMed 23257990

  • Rennotte MT, Baele P, Aubert G, Rodenstein DO. Nasal continuous positive airway pressure in the perioperative management of patients with obstructive sleep apnea submitted to surgery. Chest. 1995 Feb;107(2):367-74. doi: 10.1378/chest.107.2.367.

    PubMed 7842763

  • Latina JM, Estes NA 3rd, Garlitski AC. The Relationship between Obstructive Sleep Apnea and Atrial Fibrillation: A Complex Interplay. Pulm Med. 2013;2013:621736. doi: 10.1155/2013/621736. Epub 2013 Feb 26.

    PubMed 23533751

  • Gupta S, Cepeda-Valery B, Romero-Corral A, Shamsuzzaman A, Somers VK, Pressman GS. Association between QRS duration and obstructive sleep apnea. J Clin Sleep Med. 2012 Dec 15;8(6):649-54. doi: 10.5664/jcsm.2256.

    PubMed 23243398

  • Filgueiras-Rama D, Arias MA, Iniesta A, Armada E, Merino JL, Peinado R, Lopez-Sendon JL. Atrial arrhythmias in obstructive sleep apnea: underlying mechanisms and implications in the clinical setting. Pulm Med. 2013;2013:426758. doi: 10.1155/2013/426758. Epub 2013 Apr 3.

    PubMed 23691306

  • Rossi VA, Stradling JR, Kohler M. Effects of obstructive sleep apnoea on heart rhythm. Eur Respir J. 2013 Jun;41(6):1439-51. doi: 10.1183/09031936.00128412. Epub 2012 Dec 20.

    PubMed 23258782

  • Gami AS, Olson EJ, Shen WK, Wright RS, Ballman KV, Hodge DO, Herges RM, Howard DE, Somers VK. Obstructive sleep apnea and the risk of sudden cardiac death: a longitudinal study of 10,701 adults. J Am Coll Cardiol. 2013 Aug 13;62(7):610-6. doi: 10.1016/j.jacc.2013.04.080. Epub 2013 Jun 13.

    PubMed 23770166

  • Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.

    PubMed 18431116

  • Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.

    PubMed 22401881

  • Chouchou F, Poupard L, Philippe C, Court-Fortune I, Barthelemy JC, Roche F. Thoracic impedance, in association with oximetry, in a multi-modal ECG Holter system is useful for screening sleep disordered breathing. Int J Cardiol. 2013 Feb 10;163(1):100-2. doi: 10.1016/j.ijcard.2012.06.082. Epub 2012 Jul 16. No abstract available.

    PubMed 22805548

Questions about this trial

What is this clinical trial studying?

A study testing Measure of ODI and heart rhythm in people with Obstructive Sleep Apnea and Arrhythmia, run by University Hospital, Grenoble.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in heart rhythm troubles linked to hypoxemia events (time frame: Before surgery and at first and third night after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02833662, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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