Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).

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

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

Study Overview

• Status: Completed
• Conditions: Patient Mechanically Ventilated With APRV Mode
• Intervention / Treatment: Other: evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hôpitaux de Marseille Hôpital de la Timone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal value of transpulmonary pressure	Value of tidal volume > 8 ml/kg	24 hours

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2015-19