Clinical trial NCT01683578: Protective Variable Ventilation for Open Abdominal Surgery
Official title: Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development of Pulmonary Dysfunction Following Open Abdominal Surgery
Keywords: mechanical ventilation
lung function
abdominal surgery, open
systemic inflammation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Forced vital capacity
timeFrame: Preoperative until 5th postoperative day
Secondary outcomes:
measure: Arterial partial CO2 pressure
timeFrame: Preoperative until 5th postoperative day
measure: Peak expiratory flow
timeFrame: Preoperative until 5th postoperative day
measure: Forced expiratory volume after 1 sec
timeFrame: Preoperative until 5th postoperative day
measure: PaO2/FIO2
timeFrame: Preoperative until 5th postoperative day
measure: Distribution of ventilation
timeFrame: Preoperative until 5th postoperative day
measure: Atelectasis
timeFrame: Preoperative until 5th postoperative day
measure: Postoperative pulmonary complications
timeFrame: Preoperative until discharge from hospital
measure: Inflammation markers
timeFrame: Preoperative until 5th postoperative day
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
state: Saxony
Study officials:
affiliation: Klinikum Ludwigshafen
name: Marcelo Gama de Abreu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.