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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00800-41 | Other Identifier | RCB number |
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We need somebody to replace the principal inestigator.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With compression | Experimental | The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery. |
|
| Without compression | Active Comparator | The patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent pneumatic compression | Device | Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damien Candela, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard | 30029 | France |
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| ID | Term |
|---|---|
| D048228 | Intermittent Pneumatic Compression Devices |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Standard care | Procedure | Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery. |
|
| 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 |
| D017530 | Health Care Quality, Access, and Evaluation |