Trial Outcomes & Findings for Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy (NCT NCT02651103)
NCT ID: NCT02651103
Last Updated: 2018-10-15
Results Overview
Measured on the NIRS cerebral oxygenation monitor attached to the patient
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)
Results posted on
2018-10-15
Participant Flow
Participant milestones
| Measure |
Posterior Spinal Fusion
Patients undergoing spinal fusion surgery
NIRS: Cerebral oxygenation monitor which is standard of care for this surgery.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Posterior Spinal Fusion
n=30 Participants
Patients undergoing spinal fusion surgery
NIRS: Cerebral oxygenation monitor which is standard of care for this surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)Measured on the NIRS cerebral oxygenation monitor attached to the patient
Outcome measures
| Measure |
Posterior Spinal Fusion
n=30 Participants
Patients undergoing spinal fusion surgery
NIRS: Cerebral oxygenation monitor which is standard of care for this surgery.
|
|---|---|
|
Change in Cerebral Oxygenation Values Throughout the Procedure
Phase 1
|
83 rSO2
Standard Deviation 8
|
|
Change in Cerebral Oxygenation Values Throughout the Procedure
Phase 2
|
79 rSO2
Standard Deviation 8
|
|
Change in Cerebral Oxygenation Values Throughout the Procedure
Phase 3
|
81 rSO2
Standard Deviation 9
|
|
Change in Cerebral Oxygenation Values Throughout the Procedure
Phase 4
|
83 rSO2
Standard Deviation 8
|
Adverse Events
Posterior Spinal Fusion
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
Clinical Research Coordinator
Nationwide Children's Hospital
Phone: 6147222997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place