Delirium
Conditions
Brief summary
The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.
Detailed description
During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.
Interventions
DEVICEPSG
PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Over 60 years of age * Inpatient and scheduled for surgical procedure at MGH
Exclusion criteria
* Blindness, deafness or the inability to speak English * Inability to provide informed consent Objective Drop Criteria * Post-operative intubation greater than 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Sleep and POD | Night before surgery, approximately 13 hours | Duration of sleep in delirious vs non-delirious patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burst Suppression Ratio | Length of surgery (2-12 hours) | Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MGH Surgery Patients PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.
PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Found Ineligible | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | MGH Surgery Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 34 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 72 years STANDARD_DEVIATION 5.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Association Between Sleep and POD
Duration of sleep in delirious vs non-delirious patients
Time frame: Night before surgery, approximately 13 hours
Population: Many of the PSG data samples that were collected the night of surgery were not interpretable and poor quality.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MGH Surgery Patients | Association Between Sleep and POD | Non Delirium | 278.5 Minutes |
| MGH Surgery Patients | Association Between Sleep and POD | Delirium | 313.5 Minutes |
Secondary
Burst Suppression Ratio
Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.
Time frame: Length of surgery (2-12 hours)
Population: Only 14 EEG recordings were analyzed. EEG recordings for other patients were not analyzed due to poor quality or lack of recording due to electronic or manual error during surgery.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MGH Surgery Patients | Burst Suppression Ratio | Patients screened positive for delirium | 0.11 ratio |
| MGH Surgery Patients | Burst Suppression Ratio | Patients screened negative for delirium | 0.00 ratio |