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OpenTrials
Completed

NCT Number: NCT01683578

Protective Variable Ventilation for Open Abdominal Surgery

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.

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Key information

Conditions

Development of Pulmonary Dysfunction Following Open Abdominal Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Variable Ventilation

Other

Primary outcomes

  1. Forced vital capacity

    Time frame: Preoperative until 5th postoperative day

    Forced vital capacity is assessed on the first postoperative day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation

Acronym: PROVAR

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2012
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.