Trial Outcomes & Findings for A Prospective Study Evaluating the Use of Intraoperative Stroke Volume Variation Via the FloTrac Device to Guide Fluid and Vasopressor Management in Head and Neck Free Flaps (NCT NCT02186938)
NCT ID: NCT02186938
Last Updated: 2018-09-20
Results Overview
The primary outcome is length of ICU stay.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
Participants were assessed from entry into ICU until departure.
Results posted on
2018-09-20
Participant Flow
Participant milestones
| Measure |
Treatment Group
FloTrac device was used to manage blood pressure during surgery.
|
Control Group
FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
|
Overall Study
COMPLETED
|
38
|
44
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Study Evaluating the Use of Intraoperative Stroke Volume Variation Via the FloTrac Device to Guide Fluid and Vasopressor Management in Head and Neck Free Flaps
Baseline characteristics by cohort
| Measure |
Treatment Group
n=47 Participants
FloTrac device was used to manage blood pressure during surgery.
|
Control Group
n=47 Participants
FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
n=5 Participants
|
57.6 years
n=7 Participants
|
57.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were assessed from entry into ICU until departure.The primary outcome is length of ICU stay.
Outcome measures
| Measure |
Treatment Group
n=47 Participants
FloTrac device was used to manage blood pressure during surgery.
|
Control Group
n=47 Participants
FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.
|
|---|---|---|
|
ICU Stay
|
33.7 hours
Interval 12.5 to 102.0
|
58.3 hours
Interval 2.0 to 207.0
|
SECONDARY outcome
Timeframe: The number of participants requiring a ventilator after surgery.The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator
Outcome measures
| Measure |
Treatment Group
n=47 Participants
FloTrac device was used to manage blood pressure during surgery.
|
Control Group
n=47 Participants
FlotTrac device was not used. Blood pressure of the control group was managed with standard methods.
|
|---|---|---|
|
Number of Participants Requiring a Ventilator
|
9 participants
|
18 participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place