Perioperative Complications and Myocardial Injury Risk in Arthoplasty Patients Suspected of Having Obstructive Sleep Apnea
|ClinicalTrials.gov Identifier: NCT03281408|
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : March 18, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|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|
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.
- 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
- Troponin [ Time Frame: Post-op Day 1 ]Testing for risk of MINS (myocardial injury after non-cardiac surgery)
- Troponin [ Time Frame: Post-op Day 2 ]Testing for risk of MINS (myocardial injury after non-cardiac surgery)
- Respiratory or Cardiac Arrest [ Time Frame: 0-96 hours ]Activation of Code Blue
- Respiratory Therapy beyond standard nasal prong oxygen [ Time Frame: 0-96 hours ]
- Pneumonia [ Time Frame: 0-96 hours ]Fever with temp >=38 degree Celsius, leukocytosis and new infiltrate on CXR
- Naloxone Usage [ Time Frame: 0-96 hours ]For opioid reversal
- Airway Intervention for any cause [ Time Frame: 0-96 hours ]Use of nasal/oral airway or intubation, jaw thrust/chin lift
- Cardiac Arrhythmia [ Time Frame: 0-96 hours ]New arrhythmia requiring treatment
- Cardiac ischemia or injury [ Time Frame: 0-48 hours ]ECG changes or troponin elevation
- Transfer from normal ward bed to monitored bed [ Time Frame: 0-96 hours ]
- Transfer to local tertiary hospital [ Time Frame: 0-96 hours ]
- 30 Day Mortality [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281408
|Canada, British Columbia|
|Vancouver, British Columbia, Canada|