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Influence of Tidal Volume on Postoperative Pulmonary Function (tidalvolume)

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ClinicalTrials.gov Identifier: NCT00795964
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : September 24, 2010
Sponsor:
Information provided by:
Heinrich-Heine University, Duesseldorf

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE November 21, 2008
Last Update Posted Date September 24, 2010
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
Lung function as assessed by spirometry [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00795964 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Tidal Volume on Postoperative Pulmonary Function
Official Title  ICMJE Influence of Tidal Volume on Postoperative Pulmonary Function
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pulmonary Function
Intervention  ICMJE
  • Other: Randomized application of intraoperative tidal volume
    intraoperative mechanical ventilation with 6 ml/kg predicted body weight
    Other Name: Respiratory management
  • Other: Randomized application of intraoperative tidal volume
    intraoperative mechanical ventilation with 12 ml/kg predicted body weight
    Other Name: Respiratory management
Study Arms  ICMJE
  • Experimental: 1
    intraoperative mechanical ventilation with 6 ml/kg predicted body weight
    Intervention: Other: Randomized application of intraoperative tidal volume
  • Active Comparator: 2
    intraoperative mechanical ventilation with 12 ml/kg predicted body weight
    Intervention: Other: Randomized application of intraoperative tidal volume
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2010)
101
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2008)
100
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00795964
Other Study ID Numbers  ICMJE Intraoperative tidalvolume-25
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. med. Tanja A. Meyer-Treschan, Department of Anesthesiology
Study Sponsor  ICMJE Heinrich-Heine University, Duesseldorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tanja A Meyer-Treschan, MD Department of Anesthesiology at Duesseldorf University Hospital
PRS Account Heinrich-Heine University, Duesseldorf
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP