Influence of Tidal Volume on Postoperative Pulmonary Function

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00795964

Acronym

tidalvolume

Enrollment

101

Registered

2008-11-21

Start date

2008-09-30

Completion date

2010-09-30

Last updated

2010-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Function

Keywords

tidal volume, predicted body weight, lung function, respiratory outcome, Respiratory Function Tests, surgery

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.

Interventions

OTHERRandomized application of intraoperative tidal volume

intraoperative mechanical ventilation with 6 ml/kg predicted body weight

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Lung function as assessed by spirometry	1 year

Secondary

Measure	Time frame
lung function as assessed by blood gas analysis	1 year
time till hospital discharge	1 year
postoperative organ dysfunction	1 year
postoperative chest x-rays	1 year
time till mobilisation	1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026