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Variable ventilation has been shown to improve lung function and reduce lung damage as well as inflammation in different models of the acute respiratory distress syndrome. Also, variable ventilation is able to recruit lungs. The present study will investigate whether variable as compared to non-variable ventilation improves post-operative lung function and reduces systemic inflammation in patients submitted to open abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Variable Ventilation | Active Comparator | Variable tidal volumes with mean at 8 mL/kg of predicted body weight |
|
| Non-variable Ventilation | No Intervention | Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Variable Ventilation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced vital capacity | Forced vital capacity is assessed on the first postoperative day | Preoperative until 5th postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial partial CO2 pressure | PacO2 on the first postoperative day | Preoperative until 5th postoperative day |
| Peak expiratory flow | Preoperative until 5th postoperative day |
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Inclusion Criteria:
Exclusion Criteria:
chronic lung disease (except to COPD stadium I and II, and asthma)
Body Mass Index (BMI) > 40
allergy to one of the drugs to be used for general anesthesia
participation in another interventional trial within 4 weeks before enrollment
addiction or any other disease that may interfere with the capacity of giving informed consent
pregnant or breastfeeding women
women in reproductive age, except to those who fulfill one of the following:
indication of low compliance with the protocol
contraindication for MRI examination
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Gama de Abreu, MD, PhD | Klinikum Ludwigshafen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus | Dresden | Saxony | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29452815 | Derived | Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Conrad C, Bischlager K, Braune A, Huhle R, Insorsi A, Tarantino F, Ball L, Schultz MJ, Abolmaali N, Koch T, Pelosi P, Gama de Abreu M; PROtective Ventilation (PROVE) Network. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):581-591. doi: 10.1016/j.bja.2017.11.078. Epub 2017 Dec 1. | |
| 24885921 |
| Label | URL |
|---|---|
| Homepage of the Pulmonary Engineering Group Dresden | View source |
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| Forced expiratory volume after 1 sec | Forced expiratory volume after 1 sec (FEV1) on first postoperative day | Preoperative until 5th postoperative day |
| PaO2/FIO2 | PaO2/FIO2 during the intraoperative period | Preoperative until 5th postoperative day |
| Distribution of ventilation | Distribution of ventilation in lungs | Preoperative until 5th postoperative day |
| Atelectasis | Amount of lung atelectasis on the first postoperative day | Preoperative until 5th postoperative day |
| Postoperative pulmonary complications | Development of postoperative pulmonary complications | Preoperative until discharge from hospital |
| Inflammation markers | Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma | Preoperative until 5th postoperative day |
| Derived |
| Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Schultz MJ, Pelosi P, Koch T, Gama de Abreu M. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial. Trials. 2014 May 2;15:155. doi: 10.1186/1745-6215-15-155. |