Delirium, Sleep Apnea, Obstructive
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICECPAP
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Postoperative Delirium | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| Routine Care Routine care will be provided to the participant. | 56 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 9 |
| Overall Study | Surgery Cancelled | 3 | 2 |
Baseline characteristics
| Characteristic | CPAP | Routine Care | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 65 years | 65 years |
| Sex: Female, Male Female | 36 Participants | 32 Participants | 68 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 56 |
| serious Total, serious adverse events | 0 / 58 | 0 / 56 |
Outcome results
Primary
Presence of Postoperative Delirium
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.
Time frame: Postoperative day 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CPAP | Presence of Postoperative Delirium | DRS-R-98 severity score | 4.8 units on a scale | Standard Deviation 4.3 |
| CPAP | Presence of Postoperative Delirium | DRS-R-98 total score | 7.8 units on a scale | Standard Deviation 6.4 |
| Routine Care | Presence of Postoperative Delirium | DRS-R-98 severity score | 5.1 units on a scale | Standard Deviation 4.3 |
| Routine Care | Presence of Postoperative Delirium | DRS-R-98 total score | 8.1 units on a scale | Standard Deviation 6 |
Primary
Presence of Postoperative Delirium
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
Time frame: Postoperative day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP | Presence of Postoperative Delirium | 12 participants |
| Routine Care | Presence of Postoperative Delirium | 9 participants |