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Clinical Trials/NCT00795964
NCT00795964
Completed
Not Applicable

Influence of Tidal Volume on Postoperative Pulmonary Function

Heinrich-Heine University, Duesseldorf1 site in 1 country101 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Function
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
101
Locations
1
Primary Endpoint
Lung function as assessed by spirometry
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
September 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf

Eligibility Criteria

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

Outcomes

Primary Outcomes

Lung function as assessed by spirometry

Time Frame: 1 year

Secondary Outcomes

  • postoperative chest x-rays(1 year)
  • time till mobilisation(1 year)
  • time till hospital discharge(1 year)
  • postoperative organ dysfunction(1 year)
  • lung function as assessed by blood gas analysis(1 year)

Study Sites (1)

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