Influence of Tidal Volume on Postoperative Pulmonary Function

Not Applicable

Completed

• Conditions: Pulmonary Function
• Interventions: Other: Randomized application of intraoperative tidal volume

• Registration Number: NCT00795964
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

Lung function impairment is common after abdominal surgery. Few preventive strategies exist against postoperative lung function impairment. A new potential preventive strategy against postoperative lung function impairment comes from research on critically ill patients with severe respiratory failure. In this field research has long focused on influence of breathing volume (= tidal volume) during mechanical ventilation on outcome. It has been shown, that low tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes. Therefore, we propose a patient and investigator blinded randomised trial to test the hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to high tidal volumes reduces postoperative lung function impairment in high risk patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• written informed consent
• age ≥ 50 years and ASA classification ≥ II
• elective upper abdominal surgery of at least 3 hours duration
• general anaesthesia plus epidural anaesthesia.

Exclusion Criteria

• < 18 years of age
• impaired mental state
• unwillingness to participate
• pregnancy
• duration of surgery < 3 hours
• ASA physical status ≥ IV
• increased intracranial pressure
• neuromuscular disease that impairs spontaneous breathing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Randomized application of intraoperative tidal volume	intraoperative mechanical ventilation with 6 ml/kg predicted body weight
2	Randomized application of intraoperative tidal volume	intraoperative mechanical ventilation with 12 ml/kg predicted body weight

Primary Outcome Measures

Name	Time	Method
Lung function as assessed by spirometry	1 year

Secondary Outcome Measures

Name	Time	Method
lung function as assessed by blood gas analysis	1 year
time till hospital discharge	1 year
postoperative organ dysfunction	1 year
postoperative chest x-rays	1 year
time till mobilisation	1 year

Trial Locations

Locations (1)

Department of Anesthesiology; 🇩🇪 Duesseldorf, Germany