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Perioperative Complications and Myocardial Injury Risk in Arthoplasty Patients Suspected of Having Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03281408
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
Vancouver Coastal Health Research Institute
Information provided by (Responsible Party):
Steven Lee, University of British Columbia

Brief Summary:

Obstructive Sleep Apnea (OSA) is a common and under-diagnosed breathing disorder characterized by recurrent partial or complete collapse of the upper airway (tongue, soft palate) during sleep. It causes recurrent episodes of asphyxia (suffocation) resulting in fragmented sleep, low blood oxygen levels (hypoxemia), and high carbon dioxide concentrations. Untreated OSA is associated with serious heart/lung and metabolic diseases including strokes, diabetes, and heart attacks.

When a patient with OSA undergoes surgery, the symptoms of OSA are exacerbated afterwards due to the effects of anesthesia and related medications such as those used for pain control. This puts patients at higher risk for complications and necessitates nursing care and monitoring that are resource intensive. In many hospitals, patients with an OSA diagnosis are monitored after surgery in "high acuity" wards where the nurse to patient ratio is higher than usual. These high acuity/monitored beds are often in high demand, and their unavailability may sometimes mean cancellation of surgery or prolonged patient stay in the Post-operative Recovery Room, further causing operating room backlog.

Another serious issue is that many patients do not know they actually have the OSA condition. It is estimated that up to 20% (1) of people in the general public have OSA and that 75% (2) of them are not diagnosed. When someone with OSA goes for surgery without previously being diagnosed, special precautions in care and monitoring may not be in place, until a complication develops. For this reason, this population - those most susceptible to have OSA, but with no previous formal testing for the condition - is the most at risk for complications, and is the target group for this trial.

We plan to identify the study population by screening for OSA using the STOP-BANG questionnaire. Those who score high on this 8 item screening test have high likelihood of actually having OSA if they were to undergo formal testing and diagnosis in a Sleep Lab.

We will identify cardio-respiratory complications by conducting a chart review and determine whether admission to a "high acuity" bed had any impact. As OSA patients are at higher risk for cardiovascular complications at baseline and around the time of surgery, blood test for troponin will be performed on post-op day 1 and 2 to investigate the rate of myocardial injury. With the rate of MINS (myocardial injury after non-cardiac surgery) reported to be 8% with almost 10% 30 day mortality (per VISION trial), this pilot project which focuses on arthroplasty patients with suspected OSA, will inform us of the arthroplasty surgery specific MINS risk for comparison.


Condition or disease
Obstructive Sleep Apnea

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Obstructive Sleep Apnea Intervention Study
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort
Suspected OSA Patients Undergoing Knee or Hip Arthroplasty
These 100 subjects will be cared for and monitored in hospital following current hospital protocol. No change or intervention is to be administered. Troponin testing will be done post-op with other routine blood work.



Primary Outcome Measures :
  1. Composite Adverse Events [ Time Frame: 0-96 hours ]
    The incidence of adverse events (each listed as a secondary outcome) related to OSA combined as a composite end point

  2. Troponin [ Time Frame: Post-op Day 1 ]
    Testing for risk of MINS (myocardial injury after non-cardiac surgery)

  3. Troponin [ Time Frame: Post-op Day 2 ]
    Testing for risk of MINS (myocardial injury after non-cardiac surgery)


Secondary Outcome Measures :
  1. Respiratory or Cardiac Arrest [ Time Frame: 0-96 hours ]
    Activation of Code Blue

  2. Respiratory Therapy beyond standard nasal prong oxygen [ Time Frame: 0-96 hours ]
  3. Pneumonia [ Time Frame: 0-96 hours ]
    Fever with temp >=38 degree Celsius, leukocytosis and new infiltrate on CXR

  4. Naloxone Usage [ Time Frame: 0-96 hours ]
    For opioid reversal

  5. Airway Intervention for any cause [ Time Frame: 0-96 hours ]
    Use of nasal/oral airway or intubation, jaw thrust/chin lift

  6. Cardiac Arrhythmia [ Time Frame: 0-96 hours ]
    New arrhythmia requiring treatment

  7. Cardiac ischemia or injury [ Time Frame: 0-48 hours ]
    ECG changes or troponin elevation

  8. Transfer from normal ward bed to monitored bed [ Time Frame: 0-96 hours ]
  9. Transfer to local tertiary hospital [ Time Frame: 0-96 hours ]

Other Outcome Measures:
  1. 30 Day Mortality [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to the UBC Hospital to have knee/hip arthroplasty surgery.
Criteria

Inclusion Criteria:

  1. Patients undergoing elective primary or revision knee/hip replacement surgery.
  2. Patients with no previous OSA diagnosis (by polysomnography), who score >=5 on STOP-BANG OSA screening.

Exclusion Criteria:

  1. Patients without ability to communicate in English by reading or writing.
  2. Patients with renal failure.
  3. Patients on CPAP therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281408


Locations
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Canada, British Columbia
UBC Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Publications:
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Responsible Party: Steven Lee, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03281408    
Other Study ID Numbers: H17-01022
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases