Influence of Tidal Volume on Postoperative Pulmonary Function (tidalvolume)

September 23, 2010 updated by: Heinrich-Heine University, Duesseldorf
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
intraoperative mechanical ventilation with 6 ml/kg predicted body weight
Other: Randomized application of intraoperative tidal volume
intraoperative mechanical ventilation with 6 ml/kg predicted body weight
Other Names:
  • Respiratory management
Other: Randomized application of intraoperative tidal volume
intraoperative mechanical ventilation with 12 ml/kg predicted body weight
Other Names:
  • Respiratory management
Active Comparator: 2
intraoperative mechanical ventilation with 12 ml/kg predicted body weight
Other: Randomized application of intraoperative tidal volume
intraoperative mechanical ventilation with 6 ml/kg predicted body weight
Other Names:
  • Respiratory management
Other: Randomized application of intraoperative tidal volume
intraoperative mechanical ventilation with 12 ml/kg predicted body weight
Other Names:
  • Respiratory management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lung function as assessed by spirometry
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
lung function as assessed by blood gas analysis
Time Frame: 1 year
1 year
time till hospital discharge
Time Frame: 1 year
1 year
postoperative organ dysfunction
Time Frame: 1 year
1 year
postoperative chest x-rays
Time Frame: 1 year
1 year
time till mobilisation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Tanja A Meyer-Treschan, MD, Department of Anesthesiology at Duesseldorf University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

September 24, 2010

Last Update Submitted That Met QC Criteria

September 23, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Intraoperative tidalvolume-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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