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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04067154
Other study ID # 2425
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2012
Est. completion date August 1, 2014

Study information

Verified date August 2019
Source Policlinico Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results


Description:

In ARDS patients on mechanical ventilation, we will compare model-based estimation of gas exchange parameters (shunt, ventilation/perfusion mismatch) with CT-based estimation of effects of low and high PEEP


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date August 1, 2014
Est. primary completion date August 1, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ARDS patients requiring mechanical ventilation

Exclusion Criteria:

- <18 years old

- Requirement of extracorporal life support

- Hemodynamic instability

- Barotrauma

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ALPE
Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O Measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano MI

Sponsors (1)

Lead Sponsor Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gas Exchange and lung recruitability at diferent PEEP levels Gas exchange (At PEEP 5 and 20 cm H2O), CT scan (At PEEP 5, 20 and 45 cm H2O) Approximately two hours
Secondary Physiologic Parameter 1 Hemodynamic assessment at different PEEP levels Approximately two hours
Secondary Physiologic Parameter 2 Respiratory mechanics at different PEEP levels Approximately two hours
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