Mechanical Ventilation- Weaning and Thoracic Impedance Tomography

Weaning From Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03018483
• Other study ID #: PSWEAN and EIT
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Federico II University
• Contact: Maria Vargas
• Phone: +39 3396876440
• Email: vargas.maria82[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 342
• Est. completion date: December 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weaning From Mechanical Ventilation

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	University of Naples	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weaning time	weaning time defined as the time from randomization to successful extubation.	within 6 hours