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CompletedNCT02866513Updated Nov 14, 2017

Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).

An interventional study of evaluate the variations of transpulmonary pressure during the use of APRV by clinicians. in Patient Mechanically Ventilated With APRV Mode, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-14.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2016, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Patient Mechanically Ventilated With APRV Mode
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Contraindication for the use of a nasogastric tube
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Patient mechanically ventilated with APRV mode

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

Interventions

  • Otherevaluate the variations of transpulmonary pressure during the use of APRV by clinicians.
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours

Secondary outcomes

  1. Maximal value of transpulmonary pressure

    Value of tidal volume \> 8 ml/kg

    Time frame: 24 hours

07

Study locations

1 site
  • Assistance Publique Hôpitaux de Marseille hôpital de la Timone
    Marseille, 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02866513
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Aug 15, 2016
Start date
Feb 2016
Primary completion
Dec 2016
Completion
Mar 2017
Last update
Nov 14, 2017

Study contacts

Urielle DESALBRES
study director · Assistance Publique Hôpitaux de Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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