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CompletedNCT01683578PROVARUpdated Mar 31, 2016

Protective Variable Ventilation for Open Abdominal Surgery

An interventional study of Variable Ventilation in Development of Pulmonary Dysfunction Following Open Abdominal Surgery, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-03-31.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Development of Pulmonary Dysfunction Following Open Abdominal Surgery

Keywords

  • mechanical ventilation
  • lung function
  • abdominal surgery, open
  • systemic inflammation
03

In context

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

Browse Technische Universität Dresden studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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

Interventions

  • OtherVariable Ventilation
06

What researchers measure

Primary outcomes

  1. Forced vital capacity

    Forced vital capacity is assessed on the first postoperative day

    Time frame: Preoperative until 5th postoperative day

Secondary outcomes

  1. Arterial partial CO2 pressure

    PacO2 on the first postoperative day

    Time frame: Preoperative until 5th postoperative day

  2. Peak expiratory flow

    Time frame: Preoperative until 5th postoperative day

  3. Forced expiratory volume after 1 sec

    Forced expiratory volume after 1 sec (FEV1) on first postoperative day

    Time frame: Preoperative until 5th postoperative day

  4. PaO2/FIO2

    PaO2/FIO2 during the intraoperative period

    Time frame: Preoperative until 5th postoperative day

  5. Distribution of ventilation

    Distribution of ventilation in lungs

    Time frame: Preoperative until 5th postoperative day

  6. Atelectasis

    Amount of lung atelectasis on the first postoperative day

    Time frame: Preoperative until 5th postoperative day

  7. Postoperative pulmonary complications

    Development of postoperative pulmonary complications

    Time frame: Preoperative until discharge from hospital

  8. Inflammation markers

    Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma

    Time frame: Preoperative until 5th postoperative day

07

Study locations

1 site
  • Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
    Dresden, Saxony 01307, Germany
08

References and documents

Publications

  • Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Conrad C, Bischlager K, Braune A, Huhle R, Insorsi A, Tarantino F, Ball L, Schultz MJ, Abolmaali N, Koch T, Pelosi P, Gama de Abreu M; PROtective Ventilation (PROVE) Network. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):581-591. doi: 10.1016/j.bja.2017.11.078. Epub 2017 Dec 1. PubMed 29452815 ↗
  • Spieth PM, Guldner 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. PubMed 24885921 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012, a primary completion of Sep 2013 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2012
First posted
Sep 12, 2012
Start
Sep 2012
Primary completionActual
Sep 2013
CompletionActual
Sep 2013
Last update
Mar 31, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01683578
Lead sponsor
Technische Universität Dresden
Responsible party
Sponsor
First posted
Sep 12, 2012
Start date
Sep 2012
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Mar 31, 2016

Study contacts

Marcelo Gama de Abreu, MD, PhD
principal investigator · Klinikum Ludwigshafen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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