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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?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02123225
Enrollment
93
Registered
2014-04-25
Start date
2013-12-31
Completion date
2017-05-12
Last updated
2017-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Total Knee Arthroplasty

Keywords

STOP-BANG, Obstructive sleep apnea (OSA), total knee arthroplasty (TKA), portable monitoring, sleep medicine, unattended sleep study, postoperative sleep study

Brief summary

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).

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.

Interventions

None listed

Sponsors

United States Naval Medical Center, San Diego
Lead SponsorFED

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Apnea Hypopnea IndexBaseline through postoperative night 3Measuring changes in the apnea hypopnea index on postoperative nights 1, 2, and 3 with unattended polysomnography.

Secondary

MeasureTime frameDescription
Change in time with oxygen saturation <85%Baseline through postoperative night 3Measuring changes in the total time with oxygen saturations \<85% on postoperative nights 1, 2 & 3 with unattended polysomnography.
Change in time with oxygen saturation <90%Baseline through postoperative night 3Measuring changes in the total time with oxygen saturations \<90% on postoperative nights 1, 2 & 3 with unattended polysomnography.

Other

MeasureTime frameDescription
Change in number of central apneasBaseline through postoperative night 3Measuring changes in the total time number of central apnea episodes with unattended polysomnography between postoperative nights, 1,2, and 3.
Composite Complication Rate6 weeks postoperativelyDefined 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026