Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Completed

CT.gov ID

NCT02866513

Collaborator

(none)

Enrollment

Location

Arm

12.9

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Patient Mechanically Ventilated With APRV Mode	Other: evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Incidence of High Levels of Transpulmonary Pressure During the Use of Airway Pressure Release Ventilation.

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Patient mechanically ventilated with APRV mode	Other: evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.

Arm

Intervention/Treatment

Other: Patient mechanically ventilated with APRV mode

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

Outcome Measures

Primary Outcome Measures

Transpulmonary pressure [24 hours]
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.

Secondary Outcome Measures

Maximal value of transpulmonary pressure [24 hours]
Value of tidal volume > 8 ml/kg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Marseille hôpital de la Timone	Marseille		France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: Urielle DESALBRES, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT02866513

Other Study ID Numbers:

2015-19

First Posted:

Aug 15, 2016

Last Update Posted:

Nov 14, 2017

Last Verified:

Aug 1, 2016

Study Results

No Results Posted as of Nov 14, 2017