Trial Outcomes & Findings for Effect of CPAP on Postoperative Delirium (NCT NCT01816685)

Results Overview

Assessments for delirium were made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool. The DRS-R-98 is a 16-item clinician-rated scale that consists of a severity score (maximum score 39, minimum 0) made up of items that can be used for repeated serial measurements and a total scale score (maximum score 46, minimum 0) that includes the severity score plus three diagnostic items (7 additional possible points) used for initial ratings. Items represent symptoms that are rated on a scale of 0 to 3 points, with text descriptions for each point. Higher scores on the scale represents a larger number of delirium symptoms or increased severity of those symptoms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

135 participants

Primary outcome timeframe

Postoperative day 2

Results posted on

2015-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	CPAP Patients in the continuous positive airway pressure (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.	Routine Care Routine care will be provided to the participant.
Overall Study STARTED	68	67
Overall Study COMPLETED	58	56
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Reasons for withdrawal
Measure	CPAP Patients in the continuous positive airway pressure (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.	Routine Care Routine care will be provided to the participant.
Overall Study Lost to Follow-up	7	9
Overall Study Surgery Cancelled	3	2

Baseline Characteristics

Effect of CPAP on Postoperative Delirium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPAP n=58 Participants Patients in the continuous positive airway pressure (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.	Routine Care n=56 Participants Routine care will be provided to the participant.	Total n=114 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	32 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative day 2

Assessments for delirium were made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool. The DRS-R-98 is a 16-item clinician-rated scale that consists of a severity score (maximum score 39, minimum 0) made up of items that can be used for repeated serial measurements and a total scale score (maximum score 46, minimum 0) that includes the severity score plus three diagnostic items (7 additional possible points) used for initial ratings. Items represent symptoms that are rated on a scale of 0 to 3 points, with text descriptions for each point. Higher scores on the scale represents a larger number of delirium symptoms or increased severity of those symptoms.

Outcome measures

Outcome measures
Measure	CPAP n=58 Participants Patients in the continuous positive airway pressure (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.	Routine Care n=56 Participants Routine care will be provided to the participant.
Presence of Postoperative Delirium DRS-R-98 severity score	4.8 units on a scale Standard Deviation 4.3	5.1 units on a scale Standard Deviation 4.3
Presence of Postoperative Delirium DRS-R-98 total score	7.8 units on a scale Standard Deviation 6.4	8.1 units on a scale Standard Deviation 6

PRIMARY outcome

Timeframe: Postoperative day 2

Assessments for delirium were made on postoperative day 2 using the Confusion Assessment Method (CAM) Diagnostic Algorithm. This binary tool identifies the presence or absence of delirium

Outcome measures

Outcome measures
Measure	CPAP n=58 Participants Patients in the continuous positive airway pressure (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.	Routine Care n=56 Participants Routine care will be provided to the participant.
Presence of Postoperative Delirium	12 participants	9 participants

Adverse Events

CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Routine Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Krystal

Duke University

Phone: (919) 668-1212

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place