Evaluation of Variable Pressure Support Ventilation in th... | NCT00786292

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

NCT00786292

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Sep 5, 2012Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Acute Lung Injury

Interventions

Assisted mechanical ventilation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 5, 2008

First Submission Date that Met QC Criteria

Nov 5, 2008

First Posted Date

Nov 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2012

Last Update Posted Date

Sep 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Noisy PSV	Other	Assisted mechanical ventilation with noisy PSV	Other: Assisted mechanical ventilation
PSV	Other	Assisted mechanical ventilation with PSV	Other: Assisted mechanical ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assisted mechanical ventilation	Other	Patients will be mechanically ventilated with noisy PSV and PSV in random sequence	Noisy PSV PSV

Measure	Description	Time Frame
Effect on the arterial oxygenation

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcelo Gama de Abreu, MD, PhD	Department of Anesthesiology, University Clinic Carl Gustav Carus, Technical University Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic Carl Gustav Carus, Technical University Dresden		Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24172538	Derived	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.

ID	Term
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases