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

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

Conditions: Major Abdominal Surgery

Treatments: Procedure: Standard care; Device: Intermittent pneumatic compression

Study type: Interventional

Funder types: Other

Identifiers

NCT01403909

LOCAL/2011/DC-04

2011-A00800-41 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

With compression

Experimental group

Description:

The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery.

Treatment:

Device: Intermittent pneumatic compression

Without compression

Active Comparator group

Description:

The patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care)

Treatment:

Procedure: Standard care