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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Major Abdominal Surgery

Intervention / Treatment
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* Device: Intermittent pneumatic compression
* Procedure: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |