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

NCT ID: NCT01403909

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Major Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

With compression

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

Group Type: EXPERIMENTAL

Intermittent pneumatic compression

Intervention Type: DEVICE

Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.

Without compression

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

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: PROCEDURE

Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.

Interventions

Intermittent pneumatic compression

Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.

Intervention Type: DEVICE

Standard care

Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien Candela, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Countries

France

Other Identifiers

2011-A00800-41

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2011/DC-04

Identifier Type: -

Identifier Source: org_study_id