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OpenTrials
Completed

NCT Number: NCT00795964

Influence of Tidal Volume on Postoperative Pulmonary Function

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.

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Key information

Conditions

Pulmonary Function

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Randomized application of intraoperative tidal volume

Other

intraoperative mechanical ventilation with 6 ml/kg predicted body weight

Other names: Respiratory management

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

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Acronym: tidalvolume

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2008
Registry last updated
Sep 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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