MedDataX Logo

Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury

NCT ID: NCT00786292

Last Updated: 2012-09-05

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

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-09-30

Brief Summary

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

Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI.

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.

Acute Lung Injury

Study Design

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

Primary Study Purpose

TREATMENT

Study Groups

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

Noisy PSV

Assisted mechanical ventilation with noisy PSV

Group Type OTHER

Assisted mechanical ventilation

Intervention Type OTHER

Patients will be mechanically ventilated with noisy PSV and PSV in random sequence

PSV

Assisted mechanical ventilation with PSV

Group Type OTHER

Assisted mechanical ventilation

Intervention Type OTHER

Patients will be mechanically ventilated with noisy PSV and PSV in random sequence

Interventions

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

Assisted mechanical ventilation

Patients will be mechanically ventilated with noisy PSV and PSV in random sequence

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* age 18 to 75 yrs
* 150 mmHg \< PaO2/FIO2 \< 300 mmHg
* mechanical ventilation with PSV or BIPAP
* less than 15 days of mechanical ventilation
* at least 20% of minute ventilation originated from spontaneous breathing

Exclusion Criteria

* BMI \> 35
* esophageal disease
* neuromuscular disease
* instable thorax
* pneumothorax
* head trauma
* brain injury
* increased intracranial pressure
* agitation
* increased need for vasoactive drugs
* chronic lung disease
* acute coronary disease
* participation in another clinical trial within the last 4 weeks at enrollment

Interruption criteria:

* acute change of mental status
* SaO2 \< 92%
* pHa \< 7.30
* respiratory rate \> 30 or \< 6 /min
* dyspnea
* diaphragm/thorax antagonism
* diaphoresis
* abnormal use of respiratory muscles
* increase of the heart rate above 120% of baseline or absolute value \< 60 or \> 130 /min
* mean arterial pressure above 120% of baseline or absolute value \< 70 or \> 110 mmHg
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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

PD Dr. Marcelo Gama de Abreu

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Marcelo Gama de Abreu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden

Locations

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

University Clinic Carl Gustav Carus, Technical University Dresden

Dresden, , Germany

Site Status

Countries

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

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Spieth PM, Guldner A, Huhle R, Beda A, Bluth T, Schreiter D, Ragaller M, Gottschlich B, Kiss T, Jaber S, Pelosi P, Koch T, Gama de Abreu M. Short-term effects of noisy pressure support ventilation in patients with acute hypoxemic respiratory failure. Crit Care. 2013 Oct 31;17(5):R261. doi: 10.1186/cc13091.

Reference Type DERIVED
PMID: 24172538 (View on PubMed)

Other Identifiers

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

EK276112007

Identifier Type: -

Identifier Source: org_study_id