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

Perioperative Obstructive Sleep Apnea Intervention Study

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • UBC Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the UBC Hospital to have knee/hip arthroplasty surgery.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Adverse Events	The incidence of adverse events (each listed as a secondary outcome) related to OSA combined as a composite end point	0-96 hours
Troponin	Testing for risk of MINS (myocardial injury after non-cardiac surgery)	Post-op Day 1
Troponin	Testing for risk of MINS (myocardial injury after non-cardiac surgery)	Post-op Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory or Cardiac Arrest	Activation of Code Blue	0-96 hours
Respiratory Therapy beyond standard nasal prong oxygen		0-96 hours
Pneumonia	Fever with temp >=38 degree Celsius, leukocytosis and new infiltrate on CXR	0-96 hours
Naloxone Usage	For opioid reversal	0-96 hours
Airway Intervention for any cause	Use of nasal/oral airway or intubation, jaw thrust/chin lift	0-96 hours
Cardiac Arrhythmia	New arrhythmia requiring treatment	0-96 hours
Cardiac ischemia or injury	ECG changes or troponin elevation	0-48 hours
Transfer from normal ward bed to monitored bed		0-96 hours
Transfer to local tertiary hospital		0-96 hours

Other Outcome Measures

Outcome Measure	Time Frame
30 Day Mortality	30 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver Coastal Health Research Institute

Publications and helpful links

General Publications

• Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
• Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): October 12, 2018

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: H17-01022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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