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

• Sponsor: Loma Linda University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01082614
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This study evaluates whether using information from a special arterial blood pressure monitor to guide how much fluid is given during surgery changes how long a patient stays in the hospital after the surgery. There is scientific evidence from using similar information from different devices that this technique might allow us to do a better job giving fluids during surgery and that this may be associated with shorter hospital stay after surgery.

Condition or Disease	Intervention/Treatment	Phase
Surgical Procedures, Operative	Device: Vigileo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Early Goal Directed Therapy in Patients Undergoing Major Abdominal Surgery
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard fluid management standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
Experimental: Goal directed therapy Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis	Device: 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%.; Other Names: Vigileo model number MHM1

Outcome Measures

Primary Outcome Measures

1. Length of Postoperative Hospital Stay [within one month]

   time in days from end of surgery to hospital discharge

Secondary Outcome Measures

1. Quality of Recovery Score on Postoperative Day 2 [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.

2. Quality of Recovery Score on Postoperative Day 4 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients requiring elective or semi-elective major abdominal surgery will be assessed for eligibility.

Exclusion Criteria:

• Age under 18 years old,

• Coagulopathy,

• Significant renal/hepatic dysfunction (creatine >50% or liver enzymes > 50% of normal values),

• Congestive heart failure,

• Cardiac arrhythmias producing irregular rhythms, and

• Patient choice.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University	Loma Linda	California	United States	92354

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: Richard L. Applegate II, MD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Davinder Ramsingh, MD, MD, Loma Linda University
• ClinicalTrials.gov Identifier: NCT01082614
• Other Study ID Numbers: 59162
• First Posted: Mar 8, 2010
• Last Update Posted: Mar 26, 2019
• Last Verified: Mar 1, 2019

Study Results

Participant Flow

Arm/Group Title	Standard Fluid Management	Goal Directed Therapy
Arm/Group Description	Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	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%.
Period Title: Overall Study
STARTED	23	23
COMPLETED	20	18
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Standard Fluid Management	Goal Directed Therapy	Total
Arm/Group Description	Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	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 of all reporting groups
Overall Participants	20	18	38
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 40%	13 72.2%	21 55.3%
>=65 years	12 60%	5 27.8%	17 44.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.4 (15.8)	53.5 (16.2)	58.95 (16)
Sex: Female, Male (Count of Participants)
Female	14 70%	13 72.2%	27 71.1%
Male	6 30%	5 27.8%	11 28.9%
Region of Enrollment (participants) [Number]
United States	20 100%	18 100%	38 100%

Outcome Measures

1. Primary Outcome

Title	Length of Postoperative Hospital Stay
Description	time in days from end of surgery to hospital discharge
Time Frame	within one month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Fluid Management	Goal Directed Therapy
Arm/Group Description	Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	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%.
Measure Participants	20	18
Mean (Full Range) [Days]	7.5	5.0

2. Secondary Outcome

Title	Quality of Recovery Score on Postoperative Day 2
Description	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.
Time Frame	Postoperative day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Fluid Management	Goal Directed Therapy
Arm/Group Description	Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	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%.
Measure Participants	20	18
Median (Inter-Quartile Range) [units on a scale]	15.0	16.0

3. Secondary Outcome

Title	Quality of Recovery Score on Postoperative Day 4
Description	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.
Time Frame	Postoperative day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Fluid Management	Goal Directed Therapy
Arm/Group Description	Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team	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%.
Measure Participants	20	18
Median (Inter-Quartile Range) [units on a scale]	16.5	18.0

Adverse Events

Arm/Group Title	Standard Fluid Management		Goal Directed Therapy
Arm/Group Description
All Cause Mortality
	Standard Fluid Management		Goal Directed Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Fluid Management		Goal Directed Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Standard Fluid Management		Goal Directed Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.