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CompletedNCT00795964tidalvolumeUpdated Sep 24, 2010

Influence of Tidal Volume on Postoperative Pulmonary Function

An interventional study of Randomized application of intraoperative tidal volume and Randomized application of intraoperative tidal volume in Pulmonary Function, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2010-09-24.

Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Function

Keywords

  • tidal volume
  • predicted body weight
  • lung function
  • respiratory outcome
  • Respiratory Function Tests
  • surgery
03

In context

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    1

    intraoperative mechanical ventilation with 6 ml/kg predicted body weight

    Other: Randomized application of intraoperative tidal volume

  • Active comparator
    2

    intraoperative mechanical ventilation with 12 ml/kg predicted body weight

    Other: Randomized application of intraoperative tidal volume

Interventions

  • OtherRandomized application of intraoperative tidal volume

    intraoperative mechanical ventilation with 6 ml/kg predicted body weight

    Also known as: Respiratory management

  • OtherRandomized application of intraoperative tidal volume

    intraoperative mechanical ventilation with 12 ml/kg predicted body weight

    Also known as: Respiratory management

06

What researchers measure

Primary outcomes

  1. Lung function as assessed by spirometry

    Time frame: 1 year

Secondary outcomes

  1. lung function as assessed by blood gas analysis

    Time frame: 1 year

  2. time till hospital discharge

    Time frame: 1 year

  3. postoperative organ dysfunction

    Time frame: 1 year

  4. postoperative chest x-rays

    Time frame: 1 year

  5. time till mobilisation

    Time frame: 1 year

07

Study locations

1 site
  • Department of Anesthesiology
    Duesseldorf, 40225, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00795964
Lead sponsor
Heinrich-Heine University, Duesseldorf
First posted
Nov 21, 2008
Start date
Sep 2008
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Sep 24, 2010

Study contacts

Tanja A Meyer-Treschan, MD
principal investigator · Department of Anesthesiology at Duesseldorf University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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