Delirium Clinical Trial
Official title:
The Effect of Peri-operative Continuous Positive Airway Pressure (CPAP) on Postoperative Delirium in a Population at High-risk for Obstructive Sleep Apnea (OSA)
Verified date | August 2015 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 135 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Duke University | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Postoperative day 2 | No |
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 | Postoperative day 2 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
Recruiting |
NCT05891873 -
Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Recruiting |
NCT06194474 -
Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
|
||
Completed |
NCT03095417 -
Improving the Recovery and Outcome Every Day After the ICU
|
N/A | |
Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
Terminated |
NCT03337282 -
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
|
||
Not yet recruiting |
NCT04846023 -
Pediatric Delirium Screening in the PICU Via EEG
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Withdrawn |
NCT02673450 -
PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
|
||
Recruiting |
NCT03256500 -
Transcranial Direct Current Stimulation for the Treatment of Delirium
|
N/A | |
Not yet recruiting |
NCT02892968 -
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
|
N/A | |
Completed |
NCT02890927 -
Geriatric-CO-mAnagement for Cardiology Patients in the Hospital
|
N/A | |
Recruiting |
NCT03165539 -
Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
|
||
Completed |
NCT02554253 -
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
|
Phase 2 | |
Completed |
NCT02518646 -
DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
|
N/A | |
Recruiting |
NCT02305589 -
The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium
|
N/A | |
Completed |
NCT02628925 -
Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale
|
N/A |