Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery

Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery in Non-obese American Soceity of Anesthesiologists (ASA) 1-3 Patients

The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.

Study Overview

• Status: Withdrawn
• Conditions: Major Abdominal Surgery
• Intervention / Treatment: Device: Intermittent pneumatic compression; Procedure: Standard care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• Patient with ASA score 1-3
• Body mass index < 30 kg/m^2
• Patient is schelduled for major abdominal surgery (laparotomy without risk of haemorrhage whose duration is assumed to be greater than 120 min)
• The patient passes from home, directly to the hospital, without schelduled hospitalization in another department

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant
• The patient is breastfeeding
• The patient has a contra-indication for treatment necessary for the study
• ASA score > 3
• body mass index > 30 kg/m^2
• Expected surgical time of < 120 minutes
• Surgery with risk of hemorrhage
• Surgery via celioscopy
• The surgery require perineal access, thus rendering any blinding impossible
• Hepatic surgery
• Contra indication for intermittent venous compression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With compression; The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery.	Device: Intermittent pneumatic compression; Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.
Active Comparator: Without compression; The patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care)	Procedure: Standard care; Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume fluids (ml)	The total volume of infused fluids (Ringer's Lactate and HES) delivered to the patient during surgery (ml)	End of surgery (expected mean of 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotensive episodes	The number of arterial hypotension episodes (systolic pressure < 90 mmHg)	end of surgery (expected mean of 2 hours)
VEGF	Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood	end of surgery (expected mean of 2 hours)
sFlt1	Concentration (pg/ml) of soluble vascular endothelial growth factor receptor-1 (sFlt1) in blood	end of surgery (expected mean of 2 hours)
Hematocrit %		end of surgery (expected mean of 2 hours)
Albumin	Albuminemia (g/l)	end of surgery (expected mean of 2 hours)
Prothrombin (%)	Prothrombin rate in blood	end of surgery (expected mean of 2 hours)
Activated partial thromboplastin time	Activated partial thromboplastin time (seconds)	end of surgery (expected mean of 2 hours)
Presence/absence of POSSUM complications	Presence/absence of complications as defined by the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (POSSUM) criteria	28 days
Days of hospitalization	Length of hospitalization (days)	28 days
Number of days not in hospital	Number of days not in hospital	28 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Damien Candela, MD, Centre Hospitalier Universitaire de Nimes

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: LOCAL/2011/DC-04; 2011-A00800-41 (Other Identifier: RCB number)