Protective Variable Ventilation for Open Abdominal Surgery (PROVAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01683578
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : March 31, 2016
Information provided by (Responsible Party):
Technische Universität Dresden

September 3, 2012
September 12, 2012
March 31, 2016
September 2012
September 2013   (Final data collection date for primary outcome measure)
Forced vital capacity [ Time Frame: Preoperative until 5th postoperative day ]
Forced vital capacity is assessed on the first postoperative day
Same as current
Complete list of historical versions of study NCT01683578 on Archive Site
  • Arterial partial CO2 pressure [ Time Frame: Preoperative until 5th postoperative day ]
    PacO2 on the first postoperative day
  • Peak expiratory flow [ Time Frame: Preoperative until 5th postoperative day ]
  • Forced expiratory volume after 1 sec [ Time Frame: Preoperative until 5th postoperative day ]
    Forced expiratory volume after 1 sec (FEV1) on first postoperative day
  • PaO2/FIO2 [ Time Frame: Preoperative until 5th postoperative day ]
    PaO2/FIO2 during the intraoperative period
  • Distribution of ventilation [ Time Frame: Preoperative until 5th postoperative day ]
    Distribution of ventilation in lungs
  • Atelectasis [ Time Frame: Preoperative until 5th postoperative day ]
    Amount of lung atelectasis on the first postoperative day
  • Postoperative pulmonary complications [ Time Frame: Preoperative until discharge from hospital ]
    Development of postoperative pulmonary complications
  • Inflammation markers [ Time Frame: Preoperative until 5th postoperative day ]
    Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma
Same as current
Not Provided
Not Provided
Protective Variable Ventilation for Open Abdominal Surgery
Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Development of Pulmonary Dysfunction Following Open Abdominal Surgery
Other: Variable Ventilation
  • Active Comparator: Variable Ventilation
    Variable tidal volumes with mean at 8 mL/kg of predicted body weight
    Intervention: Other: Variable Ventilation
  • No Intervention: Non-variable Ventilation
    Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Technische Universität Dresden
Technische Universität Dresden
Not Provided
Principal Investigator: Marcelo Gama de Abreu, MD, PhD Klinikum Ludwigshafen
Technische Universität Dresden
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP