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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:

Study Description
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.

Condition or disease Intervention/treatment
Pulmonary Function Other: Randomized application of intraoperative tidal volume

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Tidal Volume on Postoperative Pulmonary Function
Study Start Date : September 2008
Primary Completion Date : September 2010
Study Completion Date : September 2010
Arms and Interventions

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 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


Outcome Measures

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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

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 Posted: November 21, 2008    Key Record Dates
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