NCT01670747

Brief Summary

In this study gas-exchange and respiratory mechanics variations to PEEP change will be correlated to CT lung morphological modifications assessed at different airway pressures (5, 15, 30 and 45 cmH2O).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

2.5 years

First QC Date

August 14, 2012

Last Update Submit

March 18, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Computer Tomography (CT) scan lung recruitment and CT lung weight

    Aim of the study is to determine the relationship between the opening pressures (recruitment) and closing pressures (PEEP) in order to prevent the opening and closing of the lung parenchyma

    Study day (day 1)

Study Arms (1)

ARDS

Sedated and mechanically ventilated patients admitted to ICU

Radiation: Chest computed tomography

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to ICU with diagnosis of ARDS who required mechanical ventilation

You may qualify if:

  • Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
  • Mechanical ventilation

You may not qualify if:

  • Clinical diagnosis of chronic obstructive pulmonary disease
  • Clinical diagnosis of pneumothorax
  • Haemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (3)

  • Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.

    PMID: 16641394BACKGROUND
  • Caironi P, Cressoni M, Chiumello D, Ranieri M, Quintel M, Russo SG, Cornejo R, Bugedo G, Carlesso E, Russo R, Caspani L, Gattinoni L. Lung opening and closing during ventilation of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2010 Mar 15;181(6):578-86. doi: 10.1164/rccm.200905-0787OC. Epub 2009 Nov 12.

    PMID: 19910610BACKGROUND
  • Cressoni M, Chiumello D, Algieri I, Brioni M, Chiurazzi C, Colombo A, Colombo A, Crimella F, Guanziroli M, Tomic I, Tonetti T, Luca Vergani G, Carlesso E, Gasparovic V, Gattinoni L. Opening pressures and atelectrauma in acute respiratory distress syndrome. Intensive Care Med. 2017 May;43(5):603-611. doi: 10.1007/s00134-017-4754-8. Epub 2017 Mar 10.

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chiumello Davide, MD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 22, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations