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Effect of CPAP on Postoperative Delirium

NCT ID: NCT01816685

Last Updated: 2015-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Patients undergoing elective knee and hip replacements will be prospectively enrolled. These surgical procedures all have an expected length of stay \> 3 days. Immediately following enrollment, patients will be randomized to receive CPAP or routine peri-operative care. Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.

Conditions

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Sleep Apnea, Obstructive Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CPAP

Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

Routine Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Krystal, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Duke University Medical Center

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Evans JL, Nadler JW, Preud'homme XA, Fang E, Daughtry RL, Chapman JB, Attarian D, Wellman S, Krystal AD. Pilot prospective study of post-surgery sleep and EEG predictors of post-operative delirium. Clin Neurophysiol. 2017 Aug;128(8):1421-1425. doi: 10.1016/j.clinph.2017.05.004. Epub 2017 May 17.

Reference Type DERIVED
PMID: 28618293 (View on PubMed)

Other Identifiers

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Pro00041457

Identifier Type: -

Identifier Source: org_study_id