Trial Outcomes & Findings for Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Abdominal Surgery (NCT NCT01082614)

NCT ID: NCT01082614

Last Updated: 2019-03-26

Results Overview

time in days from end of surgery to hospital discharge

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: within one month
• Results posted on: 2019-03-26

Participant Flow

Participant milestones

Measure	Standard Fluid Management Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	Goal Directed Therapy Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV \> 12%.
Overall Study STARTED	23	23
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Standard Fluid Management Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	Goal Directed Therapy Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV \> 12%.
Overall Study Adverse Event	1	4
Overall Study Equipment Malfunction	0	1
Overall Study Physician Decision	2	0

Baseline Characteristics

Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Abdominal Surgery

Baseline characteristics by cohort

Measure	Standard Fluid Management n=20 Participants Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	Goal Directed Therapy n=18 Participants Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV \> 12%.	Total n=38 Participants Total of all reporting groups
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	64.4 years STANDARD_DEVIATION 15.8 • n=5 Participants	53.5 years STANDARD_DEVIATION 16.2 • n=7 Participants	58.95 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: within one month

time in days from end of surgery to hospital discharge

Outcome measures

Measure	Standard Fluid Management n=20 Participants Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	Goal Directed Therapy n=18 Participants Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV \> 12%.
Length of Postoperative Hospital Stay	7.5 Days Interval 5.25 to 10.75	5.0 Days Interval 3.75 to 8.25

SECONDARY outcome

Timeframe: Postoperative day 2

Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery after surgery.

Outcome measures

Measure	Standard Fluid Management n=20 Participants Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	Goal Directed Therapy n=18 Participants Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV \> 12%.
Quality of Recovery Score on Postoperative Day 2	15.0 units on a scale Interval 14.0 to 15.75	16.0 units on a scale Interval 14.75 to 17.0

SECONDARY outcome

Timeframe: Postoperative day 4

Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery following surgery.

Outcome measures

Measure	Standard Fluid Management n=20 Participants Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	Goal Directed Therapy n=18 Participants Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV \> 12%.
Quality of Recovery Score on Postoperative Day 4	16.5 units on a scale Interval 15.0 to 18.0	18.0 units on a scale Interval 17.0 to 18.0

Adverse Events

Standard Fluid Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Goal Directed Therapy

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

Tonya Hamilton

Loma Linda University

Phone: 909-558-9408

Email: thamilton@llu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place