Protective Variable Ventilation for Open Abdominal Surgery (PROVAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Development of Pulmonary Dysfunction Following Open Abdominal Surgery
• Intervention / Treatment: Other: Variable Ventilation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity	Forced vital capacity is assessed on the first postoperative day	Preoperative until 5th postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial partial CO2 pressure	PacO2 on the first postoperative day	Preoperative until 5th postoperative day
Peak expiratory flow		Preoperative until 5th postoperative day
Forced expiratory volume after 1 sec	Forced expiratory volume after 1 sec (FEV1) on first postoperative day	Preoperative until 5th postoperative day
PaO2/FIO2	PaO2/FIO2 during the intraoperative period	Preoperative until 5th postoperative day
Distribution of ventilation	Distribution of ventilation in lungs	Preoperative until 5th postoperative day
Atelectasis	Amount of lung atelectasis on the first postoperative day	Preoperative until 5th postoperative day
Postoperative pulmonary complications	Development of postoperative pulmonary complications	Preoperative until discharge from hospital
Inflammation markers	Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma	Preoperative until 5th postoperative day

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.

Helpful Links

• Homepage of the Pulmonary Engineering Group Dresden

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (ESTIMATE): September 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: lung function; mechanical ventilation; systemic inflammation; abdominal surgery, open
• Other Study ID Numbers: PulmEngineering-2012-01