Lung Sonography in Patients With Acute Respiratory Distre... | NCT01881061

Studies
Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit

NCT01881061

Sponsor

University of Athens

Status

Completed

Last Update Posted

Jun 19, 2013Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

ARDS

Interventions

Not provided

Countries

Greece

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

Jun 2013

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

Sep 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 17, 2013

First Submission Date that Met QC Criteria

Jun 18, 2013

First Posted Date

Jun 19, 2013Estimated

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

Jun 18, 2013

Last Update Posted Date

Jun 19, 2013Estimated

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 evaluate the role of lung sonography during different PEEP settings in ICU patients with ARDS.

Detailed Description

Acute respiratory distress syndrome (ARDS) is a clinical syndrome that often occurs in critically ill patients.

Patients with ARDS invariably require mechanical ventilation to improve oxygen transport. An improvement in oxygenation can be obtained by an increase in positive end-expiratory pressure (PEEP).

In critically ill patients with ARDS, lung imaging is been held by the use of chest radiography and the "gold standard" technique, Computed Tomography (CT).

We designed an observational study in which we included patients under mechanical ventilation admitted in our ICU. In all patients PEEP changes were applied and lung sonography was performed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

10Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non aerated lung area changes		20 min after PEEP trial

Secondary Outcomes

Measure	Description	Time Frame
Arterial oxygen and carbon dioxide partial pressure		20 min after PEEP trial

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Critically ill patients with ARDS admitted in ICU of Evangelismos Hospital
length of stay > 48 hours

Exclusion Criteria:

age < 18 years
emphysema fractures or skin lesions that do not allow the implementation of lung sonography
BMI > 35 kg/m2
length of stay < 48 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

ICU population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Serafim Nanas, MD	University of Athens	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Critical Care Unit, Evaggelismos Hospital, School of Medicine, University of Athens		Athens	Attica	10676	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21816054	Result	Stefanidis K, Dimopoulos S, Tripodaki ES, Vitzilaios K, Politis P, Piperopoulos P, Nanas S. Lung sonography and recruitment in patients with early acute respiratory distress syndrome: a pilot study. Crit Care. 2011 Aug 4;15(4):R185. doi: 10.1186/cc10338.