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

Obstructive Sleep Apnea Clinical Trial

Official title:

Perioperative Obstructive Sleep Apnea Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281408
• Other study ID #: H17-01022
• Status: Completed
• Start date: December 4, 2017
• Est. completion date: October 12, 2018

Study information

• Verified date: March 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 12, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Canada	UBC Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30 Day Mortality		30 days
Primary	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
Primary	Troponin	Testing for risk of MINS (myocardial injury after non-cardiac surgery)	Post-op Day 1
Primary	Troponin	Testing for risk of MINS (myocardial injury after non-cardiac surgery)	Post-op Day 2
Secondary	Respiratory or Cardiac Arrest	Activation of Code Blue	0-96 hours
Secondary	Respiratory Therapy beyond standard nasal prong oxygen		0-96 hours
Secondary	Pneumonia	Fever with temp >=38 degree Celsius, leukocytosis and new infiltrate on CXR	0-96 hours
Secondary	Naloxone Usage	For opioid reversal	0-96 hours
Secondary	Airway Intervention for any cause	Use of nasal/oral airway or intubation, jaw thrust/chin lift	0-96 hours
Secondary	Cardiac Arrhythmia	New arrhythmia requiring treatment	0-96 hours
Secondary	Cardiac ischemia or injury	ECG changes or troponin elevation	0-48 hours
Secondary	Transfer from normal ward bed to monitored bed		0-96 hours
Secondary	Transfer to local tertiary hospital		0-96 hours