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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.
 
ClinicalTrials.gov Identifier: NCT01683578
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 12, 2012
Last Update Posted Date March 31, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
Forced vital capacity [ Time Frame: Preoperative until 5th postoperative day ]
Forced vital capacity is assessed on the first postoperative day
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protective Variable Ventilation for Open Abdominal Surgery
Official Title  ICMJE Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Development of Pulmonary Dysfunction Following Open Abdominal Surgery
Intervention  ICMJE Other: Variable Ventilation
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01683578
Other Study ID Numbers  ICMJE PulmEngineering-2012-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Technische Universität Dresden
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcelo Gama de Abreu, MD, PhD Klinikum Ludwigshafen
PRS Account Technische Universität Dresden
Verification Date March 2016

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