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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02866513
Other study ID # 2015-19
Secondary ID
Status Completed
Phase N/A
First received August 2, 2016
Last updated November 13, 2017
Start date February 2016
Est. completion date March 2017

Study information

Verified date August 2016
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like APRV could generate high levels of transpulmonary pressure.

The aim of this study is to evaluate the variations of transpulmonary pressure during the use of APRV by clinicians


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult

- Patient mechanically ventilated for more than 48 H for acute respiratory failure

- Decision to use of the APRV mode by clinicians in charge of the patient

Exclusion Criteria:

- Contraindication for the use of a nasogastric tube

Study Design


Related Conditions & MeSH terms

  • Patient Mechanically Ventilated With APRV Mode

Intervention

Other:
evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.


Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille hôpital de la Timone 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 Transpulmonary pressure Measurement of transpulmonary pressure needs the measurement of oesophageal pressure with a specific nasogastric tube. This measurement is now available in routine in few mechanical ventilators in intensive care units (eg: AVEA Ventilator. Vyasys HealthCare). Transpulmonary pressure is the difference between airway pressure and oesophageal pressure and it is now easy to obtain and monitor at the bedside with these ventilators. It is also possible to record the value furthermore than 24 hours. 24 hours
Secondary Maximal value of transpulmonary pressure Value of tidal volume > 8 ml/kg 24 hours