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OpenTrials
Completed

NCT Number: NCT03281408

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UBC Hospital

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  1. 30 Day Mortality

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Vancouver Coastal Health Research Institute

Registry information

Official study title

Perioperative Obstructive Sleep Apnea Intervention Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2017
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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