Influence of Tidal Volume on Postoperative Pulmonary Function (tidalvolume)

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Pulmonary Function

Treatments: Other: Randomized application of intraoperative tidal volume

Study type: Interventional

Funder types: Other

Identifiers

NCT00795964

Intraoperative tidalvolume-25

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups

1

Experimental group

Description:

intraoperative mechanical ventilation with 6 ml/kg predicted body weight

Treatment:

Other: Randomized application of intraoperative tidal volume

Other: Randomized application of intraoperative tidal volume

2

Active Comparator group

Description:

intraoperative mechanical ventilation with 12 ml/kg predicted body weight

Treatment:

Other: Randomized application of intraoperative tidal volume

Other: Randomized application of intraoperative tidal volume