Influence of Tidal Volume on Postoperative Pulmonary Function

Pulmonary Function Clinical Trial

— tidalvolume  

Official title:

Influence of Tidal Volume on Postoperative Pulmonary Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795964
• Other study ID #: Intraoperative tidalvolume-25
• Status: Completed
• Phase: N/A
• First received: November 20, 2008
• Last updated: September 23, 2010
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pulmonary Function

Intervention

Other:
• Randomized application of intraoperative tidal volume
intraoperative mechanical ventilation with 6 ml/kg predicted body weight
• Randomized application of intraoperative tidal volume
intraoperative mechanical ventilation with 12 ml/kg predicted body weight

Locations

Country	Name	City	State
Germany	Department of Anesthesiology	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function as assessed by spirometry		1 year	Yes
Secondary	lung function as assessed by blood gas analysis		1 year	Yes
Secondary	time till hospital discharge		1 year	No
Secondary	postoperative organ dysfunction		1 year	Yes
Secondary	postoperative chest x-rays		1 year	No
Secondary	time till mobilisation		1 year	No