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
  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 Technische Universität Dresden:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
Investigators
Principal Investigator: Marcelo Gama de Abreu, MD, PhD Klinikum Ludwigshafen
  More Information

Additional Information:
No publications provided by Technische Universität Dresden

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität Dresden
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 Technische Universität Dresden:
mechanical ventilation
lung function
abdominal surgery, open
systemic inflammation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014