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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02885584
Other study ID # 2013-11
Secondary ID 2013-A00465-40
Status Active, not recruiting
Phase N/A
First received August 26, 2016
Last updated August 30, 2016
Start date December 2013
Est. completion date May 2017

Study information

Verified date August 2016
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

High frequency percussive ventilation (HFPV) is a high frequency ventilation mode in which high frequency pulses accumulate to generate a low frequency tidal volume at a controlled airway pressure. Previous studies have suggested a protective effect of HFPV on lung injury. The goal of our study is to compare, in early ARDS patients, the effects of conventional mechanical ventilation and of high frequency percussive ventilation on alveolar recruitment and distension evaluated by CT-scan


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date May 2017
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient undergoing invasive ventilation for more than 24h

- ARDS patient

Exclusion Criteria:

- Pneumothorax drained or not

- Patient undergoing extracorporel mechanical oxygenation

- Patient who had a pneumonectomy partiel or total

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
High frequency percussive ventilation


Locations

Country Name City State
France Assistance Publique-Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of patients exhibiting under HFPV an increase of at least 15% of normally aerated end-expiratory lung volume 4 hours No
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