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Protective Variable Ventilation for Open Abdominal Surgery (PROVAR)

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

Study Description
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.

Condition or disease Intervention/treatment
Development of Pulmonary Dysfunction Following Open Abdominal Surgery Other: Variable Ventilation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation
Study Start Date : September 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Forced vital capacity [ Time Frame: Preoperative until 5th postoperative day ]
    Forced vital capacity is assessed on the first postoperative day


Secondary Outcome Measures :
  1. Arterial partial CO2 pressure [ Time Frame: Preoperative until 5th postoperative day ]
    PacO2 on the first postoperative day

  2. Peak expiratory flow [ Time Frame: Preoperative until 5th postoperative day ]
  3. Forced expiratory volume after 1 sec [ Time Frame: Preoperative until 5th postoperative day ]
    Forced expiratory volume after 1 sec (FEV1) on first postoperative day

  4. PaO2/FIO2 [ Time Frame: Preoperative until 5th postoperative day ]
    PaO2/FIO2 during the intraoperative period

  5. Distribution of ventilation [ Time Frame: Preoperative until 5th postoperative day ]
    Distribution of ventilation in lungs

  6. Atelectasis [ Time Frame: Preoperative until 5th postoperative day ]
    Amount of lung atelectasis on the first postoperative day

  7. Postoperative pulmonary complications [ Time Frame: Preoperative until discharge from hospital ]
    Development of postoperative pulmonary complications

  8. Inflammation markers [ Time Frame: Preoperative until 5th postoperative day ]
    Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683578


Locations
Germany
Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Marcelo Gama de Abreu, MD, PhD Klinikum Ludwigshafen
More Information

Additional Information:
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
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by Technische Universität Dresden:
mechanical ventilation
lung function
abdominal surgery, open
systemic inflammation