Protective Variable Ventilation for Open Abdominal Surgery (PROVAR)

This study is currently recruiting participants.

Verified September 2012 by Dresden University of Technology

Sponsor:

Information provided by (Responsible Party):

Dresden University of Technology

ClinicalTrials.gov Identifier:

NCT01683578

First received: September 3, 2012

Last updated: September 10, 2012

Last verified: September 2012

History of Changes

Purpose

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.

Condition	Intervention
Development of Pulmonary Dysfunction Following Open Abdominal Surgery	Other: Variable Ventilation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Forced vital capacity [ Time Frame: Preoperative until 5th postoperative day ] [ Designated as safety issue: No ]
Forced vital capacity is assessed on the first postoperative day

Secondary Outcome Measures:

Arterial partial CO2 pressure [ Time Frame: Preoperative until 5th postoperative day ] [ Designated as safety issue: No ]
PacO2 on the first postoperative day
Peak expiratory flow [ Time Frame: Preoperative until 5th postoperative day ] [ Designated as safety issue: No ]
Forced expiratory volume after 1 sec [ Time Frame: Preoperative until 5th postoperative day ] [ Designated as safety issue: No ]
Forced expiratory volume after 1 sec (FEV1) on first postoperative day
PaO2/FIO2 [ Time Frame: Preoperative until 5th postoperative day ] [ Designated as safety issue: No ]
PaO2/FIO2 during the intraoperative period
Distribution of ventilation [ Time Frame: Preoperative until 5th postoperative day ] [ Designated as safety issue: No ]
Distribution of ventilation in lungs
Atelectasis [ Time Frame: Preoperative until 5th postoperative day ] [ Designated as safety issue: Yes ]
Amount of lung atelectasis on the first postoperative day
Postoperative pulmonary complications [ Time Frame: Preoperative until discharge from hospital ] [ Designated as safety issue: No ]
Development of postoperative pulmonary complications
Inflammation markers [ Time Frame: Preoperative until 5th postoperative day ] [ Designated as safety issue: No ]
Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma

Estimated Enrollment:	50
Study Start Date:	September 2012

Arms	Assigned Interventions
Active Comparator: Variable Ventilation Variable tidal volumes with mean at 8 mL/kg of predicted body weight	Other: Variable Ventilation
No Intervention: Non-variable Ventilation Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

elective open abdominal surgery
ASA classification 2-3
age between 18 und 85 yrs
expected duration of surgery > 3 h
expected extubation in the operation room
written informed consent

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:
- post-menopause (12 months natural amenorrhoea, or 6 months amenorrhoea and serum FSH > 40 mlU/ml
- post-operative (6 weeks after two-sided ovariectomy)
- routine and correct use of anticonceptional methods with failure rate < 1 % per year
- sexually not active
- vasectomy of the partner
indication of low compliance with the protocol
contraindication for MRI examination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683578

Contacts

Contact: Marcelo Gama de Abreu, MD, PhD	+493514584488	mgabreu@uniklinikum-dresden.de
Contact: Peter M Spieth, MD	+4935145816006	peter.spieth@uniklinikum-dresden.de

Locations

Germany
Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus	Recruiting
Dresden, Saxony, Germany, 01307
Contact: Marcelo Gama de Abreu, MD, PhD +493514584488 mgabreu@uniklinikum-dresden.de
Principal Investigator: Marcelo Gama de Abreu, MD, PhD

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Marcelo Gama de Abreu, MD, PhD

Klinikum Ludwigshafen

More Information

Additional Information:

Homepage of the Pulmonary Engineering Group Dresden This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT01683578 History of Changes
Other Study ID Numbers:	PulmEngineering-2012-01
Study First Received:	September 3, 2012
Last Updated:	September 10, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

mechanical ventilation
lung function
abdominal surgery, open
systemic inflammation

Additional relevant MeSH terms:

Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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