Influence of Tidal Volume on Postoperative Pulmonary Function (tidalvolume)

This study has been completed.
Sponsor:
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00795964
First received: November 20, 2008
Last updated: September 23, 2010
Last verified: September 2010
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • lung function as assessed by blood gas analysis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • time till hospital discharge [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • postoperative organ dysfunction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • postoperative chest x-rays [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • time till mobilisation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 20, 2008
Last Updated: September 23, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 19, 2014