Protective Variable Ventilation for Open Abdominal Surgery

Not Applicable

Completed

• Conditions: Development of Pulmonary Dysfunction Following Open Abdominal Surgery
• Interventions: Other: Variable Ventilation

• Registration Number: NCT01683578
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Variable Ventilation	Variable Ventilation	Variable tidal volumes with mean at 8 mL/kg of predicted body weight

Primary Outcome Measures

Name	Time	Method
Forced vital capacity	Preoperative until 5th postoperative day	Forced vital capacity is assessed on the first postoperative day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus; 🇩🇪 Dresden, Saxony, Germany