Protective Variable Ventilation for Open Abdominal Surgery (PROVAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Technische Universität Dresden
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01683578
First received: September 3, 2012
Last updated: September 10, 2012
Last verified: September 2012

September 3, 2012
September 10, 2012
September 2012
Not Provided
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
Same as current
Complete list of historical versions of study NCT01683578 on ClinicalTrials.gov Archive Site
  • 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
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Spieth PM, Güldner 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
Not Provided

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
Both
18 Years to 85 Years
No
Contact: Marcelo Gama de Abreu, MD, PhD +493514584488 mgabreu@uniklinikum-dresden.de
Contact: Peter M Spieth, MD +4935145816006 peter.spieth@uniklinikum-dresden.de
Germany
 
NCT01683578
PulmEngineering-2012-01
No
Technische Universität Dresden
Technische Universität Dresden
Not Provided
Principal Investigator: Marcelo Gama de Abreu, MD, PhD Klinikum Ludwigshafen
Technische Universität Dresden
September 2012

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