Is the STOP-BANG Predictive of Worsening OSA in the Early Postop Period in Patients Undergoing TJA?

Is the STOP-BANG Predictive of Worsening Obstructive Sleep Apnea in the Early Postoperative Period in Patients Undergoing Total Joint Arthroplasty?

The goal of this study is to determine if the investigators can use the STOP-BANG score to identify those patients at risk for worsening Obstructive Sleep Apnea (OSA) symptoms in the early postoperative period after major surgery.

Hypotheses:

1. - Postoperative sleep apnea parameters will be worse when compared to baseline in patients with higher scores on the STOP-BANG.
2. - A higher STOP-BANG score will be predictive of worsening sleep apnea parameters in patients undergoing Total Knee Arthroscopy (TKA).

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Total Knee Arthroplasty

Detailed Description

Obstructive sleep apnea (OSA) is associated with increased morbidity and mortality after total knee arthroplasty (TKA). Up to 30% of surgical patients have undiagnosed OSA; however, many patients are unable to obtain a sleep study prior to surgery. In recent years the STOP-BANG questionnaire (8 yes-no questions; ≥3 high-risk OSA) has become one of the most common tools used in the preoperative period to identify patients at high-risk for OSA. However, further research is needed to determine if the STOP-BANG is predictive of worsening of sleep apnea parameters in patients undergoing TKA.

The purpose of this prospective observational cohort study is to determine in TKA patients if the score on the STOP-BANG (<3, ≥3 to <5, or ≥5) is predictive of worsening sleep apnea parameters (AHI, time with SPO2 <90% & 85% [T90 & T85], lowest oxygen saturation [LSAT], & number of central apneas) during the first three days after surgery. The investigators propose to enroll N = 168 patients undergoing TKA at NMCSD who are receiving multimodal anesthesia/analgesia for surgery. Patients will complete a baseline unattended sleep study prior to surgery then again for the first three days after surgery. Patients will be categorized into three groups based on their STOP-BANG score (<3, ≥3 to <5, or ≥5) and the investigators will first compare the groups to identify if there are differences between baseline and postoperative sleep apnea parameters based on the STOP-BANG groups (<3, ≥3 to <5, or ≥5). If differences are found the investigators will use multiple regression analysis to determine if the STOP-BANG scores or categories and/or other covariates (i.e., comorbidity index, total morphine equivalents) are predictive of worsening sleep apnea during the first three days after surgery.

Results of this study may help improve patient safety by allowing us to identify which group of TKA patients with undiagnosed OSA may require more intensive postoperative monitoring and therapy (i.e, ICU admission, need for continuous end-tidal CO2 monitoring, postoperative positive airway pressure therapy) or change in the analgesic plan.

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subject population will be N = 168 patients scheduled for primary or revision TKA between the ages of 18-90, at Naval Medical Center San Diego.

Description

Inclusion Criteria:

• Age 18-90
• Scheduled for primary or revision TKA
• Able to read and understand the consent
• Able to complete an unattended OSA PM examination at home 1-60 days prior to surgery and for three days postoperatively

Exclusion Criteria:

• Polysomnography confirmed OSA
• Significant comorbid medical conditions that may degrade the accuracy of PM (moderate to severe pulmonary disease, neuromuscular disease, or congestive heart failure)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Apnea Hypopnea Index	Measuring changes in the apnea hypopnea index on postoperative nights 1, 2, and 3 with unattended polysomnography.	Baseline through postoperative night 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in time with oxygen saturation <85%	Measuring changes in the total time with oxygen saturations <85% on postoperative nights 1, 2 & 3 with unattended polysomnography.	Baseline through postoperative night 3
Change in time with oxygen saturation <90%	Measuring changes in the total time with oxygen saturations <90% on postoperative nights 1, 2 & 3 with unattended polysomnography.	Baseline through postoperative night 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of central apneas	Measuring changes in the total time number of central apnea episodes with unattended polysomnography between postoperative nights, 1,2, and 3.	Baseline through postoperative night 3
Composite Complication Rate	Defined as the incidence of composite complications: myocardial ishchemia or infarction, EKG changes, pulmonary embolism, need for CPAP, unplanned intubation, ICU admission, difficult intubation, pneumonia, or ARDS. Medical records will be reviewed to determine incidence of these complications through 6 weeks postoperatively.	6 weeks postoperatively

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, San Diego
• Investigators: Principal Investigator: Dennis L Spence, PhD, United States Naval Medical Center, San Diego

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): May 12, 2017

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: portable monitoring; STOP-BANG; Obstructive sleep apnea (OSA); sleep medicine; total knee arthroplasty (TKA); unattended sleep study; postoperative sleep 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: NMCSD.2013.0045

Plan for Individual participant data (IPD)

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