Mechanical Ventilation- Weaning and Thoracic Impedance Tomography

NCT03018483 | Unknown

• 1 other identifier: PSWEAN and EIT
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM. This study is a multicenter randomized controlled open trial comparing variable, non-variable pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation for more than 24 hours who are able to be weaned. The aim of the study is to determine the duration of weaning from mechanical ventilation for each one of the above mentioned weaning methods

Conditions

Weaning From Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• weaning time

  weaning time defined as the time from randomization to successful extubation.

  within 6 hours

Study Arms (4)

Variable PSV

EXPERIMENTAL

Device: Variable PSV

Conventional PSV

ACTIVE COMPARATOR

Device: Conventional PSV

Automated PSV

ACTIVE COMPARATOR

Device: Automated PSV

NAVA

ACTIVE COMPARATOR

Device: NAVA

Interventions

Variable PSV DEVICE

Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. In patients ventilated with variable PSV, the pressure support variability is as high as possible (up to 100%), while not exceeding the maximal inspiratory pressure determined by the treating physician.

Variable PSV

Conventional PSV DEVICE

Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. The adjustment of pressure support until extubation follows these rules for both non-variable and variable PSV groups: pressure support is gradually adjusted in decrements (or increments) of 0 to 5 cmH2O. PEEP is decreased in steps of 0 to 5 cmH2O; PEEP and FiO2 are adjusted to achieve a SaO2 ≥92%, with a PEEP ≥5 cmH2O.

Conventional PSV

Automated PSV DEVICE

Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.Smart CareTM as total automated procedure will be used.

Automated PSV

NAVA DEVICE

NAVA level is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the Edi level was increased by step of 0,2 cm/h2o/ mcvolt, PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.

NAVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age≥18 years
• duration of controlled mechanical ventilation≥ 24 h
• temperature≤ 39°C
• hemoglobin≥ 6 g/dl
• ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction - PaO2/FiO2≥150mmHg with positive end-expiratory pressure (PEEP)≤ 16 cmH2O
• ability of the patient to breathe spontaneously
• informed consent

You may not qualify if:

• patient participated in another interventional trial within the last four weeks before enrollment
• peripheral neurological disease associated with impairment of the respiratory pump
• muscular disease associated with impairment of the respiratory pump
• unstable thorax with paradoxical chest wall movement
• planned surgery under general anesthesia within 72 hours
• difficult airway or intubation
• existing tracheotomy at ICU admission
• expected survival\<72 hours
• home mechanical ventilation or on chronic oxygen therapy
• suspected or confirmed pregnancy

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples

Naples, 80100, Italy

RECRUITING

Central Study Contacts

Maria Vargas

CONTACT

+39 3396876440; vargas.maria82@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resercher

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 12, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)