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Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).

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ClinicalTrials.gov Identifier: NCT02866513
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

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



Primary Outcome Measures :
  1. Transpulmonary pressure [ Time Frame: 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 :
  1. Maximal value of transpulmonary pressure [ Time Frame: 24 hours ]
    Value of tidal volume > 8 ml/kg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866513


Locations
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France
Assistance Publique Hôpitaux de Marseille hôpital de la Timone
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02866513     History of Changes
Other Study ID Numbers: 2015-19
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: August 2016