Mechanical Ventilation- Weaning and Thoracic Impedance Tomography

Comparison Between Automated Pressure Support Ventilation, Variable Pressure Support Ventilation and Non-variable Pressure Support Ventilation in Weaning From Mechanical Ventilation

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

Study Overview

• Status: Unknown
• Conditions: Weaning From Mechanical Ventilation
• Intervention / Treatment: Device: Variable PSV; Device: Conventional PSV; Device: Automated PSV; Device: NAVA

• Study Type: Interventional
• Enrollment (Anticipated): 342
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Vargas; Phone Number: +39 3396876440; Email: vargas.maria82@gmail.com

Study Locations

• Italy
  • Naples, Italy, 80100
    • Recruiting
    • University of Naples
    • Contact: maria vargas, MD; Email: vargas.maria82@gmail.com

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:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Variable PSV	Device: Variable PSV; 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.
Active Comparator: Conventional PSV	Device: Conventional PSV; 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.
Active Comparator: Automated PSV	Device: Automated PSV; 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.
Active Comparator: NAVA	Device: NAVA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weaning time	weaning time defined as the time from randomization to successful extubation.	within 6 hours

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 8, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PSWEAN and EIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No