Impact of the Assisted Ventilation Mode on Diaphragm Efficiency in Critically Ill Patients

NCT ID: NCT02473172

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-05-31

Brief Summary

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This study evaluates the impact of the assisted mode of mechanical ventilation on diaphragm efficiency in mechanically ventilated critically ill patients. Participants will be randomized to the neurally adjusted ventilatory assist (NAVA) mode or to the pressure support ventilation (PSV) mode.

Detailed Description

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During mechanical ventilation the ventilator applies positive pressure to the respiratory system. Often in the acute phase of critical illness patients are ventilated in the control mode (CMV), where the patient is completely passive. This quickly (within 48 hours) has been shown to induce diaphragm atrophy and dysfunction (Levine et al New England Journal of Medicine, 200; 358:1327-35). To preserve diaphragm function, guidelines suggest to shift as soon as possible to the assisted mode (the ventilator applies positive pressure to assist spontaneous inspiratory effort). The synchrony between patient and ventilator is critical in this context. PSV is the classical assisted mode and applies a constant pressure whatever the patient effort. NAVA is a newer mode based on the diaphragm electrical activity (EAdi) measurement. It assist patient effort proportionally to the EAdi and hence to patient's effort. The investigator hypothesis is that NAVA would improve diaphragm efficiency more efficiently than PSV.

Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pressure Support Ventilation

Assisted mechanical ventilation

Group Type EXPERIMENTAL

Pressure Support ventilation

Intervention Type DEVICE

Assisted mechanical ventilation

Neurally Adjusted Ventilatory Assist

Assisted mechanical ventilation

Group Type EXPERIMENTAL

Neurally Adjusted Ventilatory Assist

Intervention Type DEVICE

Assisted mechanical ventilation

Interventions

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Pressure Support ventilation

Assisted mechanical ventilation

Intervention Type DEVICE

Neurally Adjusted Ventilatory Assist

Assisted mechanical ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* older than 18 years
* oro-tracheally or naso-tracheally intubate
* had been ventilated for acute respiratory failure in control mechanical ventilation for at least 72 hours consecutively
* candidate to assisted ventilation
* Hemodynamically stable without vasopressor or inotropes (excluding a dobutamine and dopamine infusion lower than 5 gamma/Kg/min and a 3 gamma /Kg/min, respectively
* normothermia

Exclusion Criteria

* Neurological or neuromuscular pathologies
* phrenic nerve dysfunction
* contraindications to the insertion of a nasogastric tube (for example recent upper gastrointestinal surgery, esophageal varices).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bari

OTHER

Sponsor Role lead

Responsible Party

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Salvatore Grasso

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salvatore Grasso, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

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Azienda Ospedaliero Universitaria Policlinico

Bari, , Italy

Site Status

Countries

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Italy

References

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Di Mussi R, Spadaro S, Mirabella L, Volta CA, Serio G, Staffieri F, Dambrosio M, Cinnella G, Bruno F, Grasso S. Impact of prolonged assisted ventilation on diaphragmatic efficiency: NAVA versus PSV. Crit Care. 2016 Jan 5;20:1. doi: 10.1186/s13054-015-1178-0.

Reference Type DERIVED
PMID: 26728475 (View on PubMed)

Other Identifiers

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NAVA_PSV

Identifier Type: -

Identifier Source: org_study_id

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