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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00876473
Other study ID # 590
Secondary ID
Status Completed
Phase N/A
First received April 3, 2009
Last updated April 27, 2015
Start date April 2009
Est. completion date January 2014

Study information

Verified date April 2015
Source Policlinico Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the performance, the tolerability and the efficacy on gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.


Description:

Three CPAP systems are studied for each patient at the same level of PEEP: 1) continuous high-flow CPAP with fixed value PEEP valve; 2) continuous high-flow CPAP with Boussignac PEEP valve; 3) demand flow CPAP, supplied by a ventilator.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Intubated-tracheostomized subjects receiving CPAP during the weaning from invasive mechanical ventilation

Exclusion Criteria:

- Hemodynamic instability

- Barotrauma

- Severe myopathy

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
CPAP system
Evaluating the effects of different CPAP systems on respiratory mechanics, respiratory effort and gas-exchange CPAP systems: Continuous high-flow CPAP with fixed value PEEP valve Continuous high-flow CPAP with Boussignac valve Demand flow CPAP supplied by ventilator

Locations

Country Name City State
Italy Policlinico Hospital Milan

Sponsors (1)

Lead Sponsor Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange 30 minutes No
Secondary Comfort of breathing 30 minutes No
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