N/A
N=135
Effect of CPAP on Postoperative Delirium
Sleep Apnea, Obstructive · Delirium
Bottom Line
View on ClinicalTrials.gov: NCT01816685 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Presence of Postoperative Delirium — 4.8; 5.1; 7.8; 8.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Postoperative Delirium |
12; 9 | — |
| PRIMARY Presence of Postoperative Delirium |
12; 9 | — |
Summary
Patients with a medical condition known as obstructive sleep apnea may be at increased risk of delirium following surgery. This study loans autotitrating CPAP machines to randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of preventing post-operative delirium.
Eligibility Criteria
Inclusion Criteria
- Age 50 and above
- Scheduled for an elective knee or hip replacement
- Ability to speak English and give informed consent
- At risk for obstructive sleep apnea as defined by a STOP-BANG score > 2
Exclusion Criteria
- History of psychiatric or neurologic illness that would confound delirium assessment
- Severe tracheal or lung disease
- Contraindications to face-mask CPAP
- Treated OSA
Data sourced from ClinicalTrials.gov (NCT01816685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.