Obstructive Sleep Apnea Clinical Trial
Official title:
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).
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |