MedDataX Logo

Influence of Tidal Volume on Postoperative Pulmonary Function

NCT ID: NCT00795964

Last Updated: 2010-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

intraoperative mechanical ventilation with 6 ml/kg predicted body weight

Group Type EXPERIMENTAL

Randomized application of intraoperative tidal volume

Intervention Type OTHER

intraoperative mechanical ventilation with 6 ml/kg predicted body weight

2

intraoperative mechanical ventilation with 12 ml/kg predicted body weight

Group Type ACTIVE_COMPARATOR

Randomized application of intraoperative tidal volume

Intervention Type OTHER

intraoperative mechanical ventilation with 12 ml/kg predicted body weight

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Randomized application of intraoperative tidal volume

intraoperative mechanical ventilation with 6 ml/kg predicted body weight

Intervention Type OTHER

Randomized application of intraoperative tidal volume

intraoperative mechanical ventilation with 12 ml/kg predicted body weight

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Respiratory management Respiratory management

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Anesthesiology

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tanja A Meyer-Treschan, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology at Duesseldorf University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology

Düsseldorf, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Intraoperative tidalvolume-25

Identifier Type: -

Identifier Source: org_study_id