PEEP Recruitment-comparison Between Ultrasonographic Asse... | NCT01478217

Studies
PEEP Recruitment-comparison Between Ultrasonographic Assessment and LIP Assessment

NCT01478217

Sponsor

Sisters of Mercy University Hospital

Status

Completed

Last Update Posted

Nov 23, 2011Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Acute Respiratory Distress Syndrome

Interventions

Not provided

Countries

Croatia

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

Nov 2011

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

Oct 2009

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Nov 20, 2011

First Submission Date that Met QC Criteria

Nov 22, 2011

First Posted Date

Nov 23, 2011Estimated

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

Nov 22, 2011

Last Update Posted Date

Nov 23, 2011Estimated

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

The purpose of this study is to compare lung recruitment in acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic ultrasonographic assessment of lung recruitment.

Detailed Description

Sedated and sometimes temporary relaxed patients with ALI/ARDS on mechanical ventilation in semirecumbent position are included. Lower inflection point on pressure volume loop on ventilator Draeger Evita 4 with low continuous flow on volume controlled ventilation is measured with zero PEEP. Transthoracic lung ultrasound with linear probe is proceed on both hemithoraces when mechanical ventilation based on measured PEEP is started. We compare if real lung recruitment seen by ultrasound is the same as predicted by lower inflection point.

The procedure is a part of routine everyday respiratory monitoring in our unit.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with diffuse ALI/ARDS on mechanical ventilation with visible lower inflection point on dynamic P-V loops

Exclusion Criteria:

preexisting parenchymal or pleural lung disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

intensive care patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bojan Rode, M.D.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central intensive care unit, University hospital "Sisters of Mercy"		Grad Zagreb		10000	Croatia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20851923	Result	Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders