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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00267241
Other study ID # 1600
Secondary ID
Status Completed
Phase N/A
First received December 19, 2005
Last updated April 27, 2015
Start date December 2005
Est. completion date November 2014

Study information

Verified date April 2015
Source Policlinico Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.


Description:

ALI/ARDS patients (during assisted ventilation) will be ventilated with different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) and gas exchange, comfort of breathing, respiratory mechanics and pattern of breathing will be measured.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with ALI/ARDS

Exclusion Criteria:

- COPD patients

- Barotrauma

- Hemodynamic instability

- Age less than 18

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Acute Lung Injury
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn

Intervention

Other:
Mechanical Ventilation
Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)

Locations

Country Name City State
Italy Policlinico Hospital Milano

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 respiratory mechanics 5 minutes No
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