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

Not Applicable

Withdrawn

• Conditions: Major Abdominal Surgery
• Interventions: Device: Intermittent pneumatic compression; Procedure: Standard care

• Registration Number: NCT01403909
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With compression	Intermittent pneumatic compression	The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery.
Without compression	Standard care	The patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France