Protective Variable Ventilation for Open Abdominal Surgery (PROVAR)

Technische Universität Dresden

Status

Completed

Conditions

Development of Pulmonary Dysfunction Following Open Abdominal Surgery

Treatments

Other: Variable Ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT01683578

PulmEngineering-2012-01

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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