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Influence of Tidal Volume on Postoperative Pulmonary Function (tidalvolume)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795964
First Posted: November 21, 2008
Last Update Posted: September 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heinrich-Heine University, Duesseldorf
  Purpose
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.

Condition Intervention
Pulmonary Function Other: Randomized application of intraoperative tidal volume

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Tidal Volume on Postoperative Pulmonary Function

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Lung function as assessed by spirometry [ Time Frame: 1 year ]

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

Enrollment: 101
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 12 ml/kg predicted body weight
Other Name: Respiratory management

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795964


Locations
Germany
Department of Anesthesiology
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Tanja A Meyer-Treschan, MD Department of Anesthesiology at Duesseldorf University Hospital
  More Information

Responsible Party: Dr. med. Tanja A. Meyer-Treschan, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00795964     History of Changes
Other Study ID Numbers: Intraoperative tidalvolume-25
First Submitted: November 20, 2008
First Posted: November 21, 2008
Last Update Posted: September 24, 2010
Last Verified: September 2010

Keywords provided by Heinrich-Heine University, Duesseldorf:
tidal volume
predicted body weight
lung function
respiratory outcome
Respiratory Function Tests
surgery


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