Mechanical Ventilation- Weaning and Thoracic Impedance Tomography

NCT ID: NCT03018483

Last Updated: 2019-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Variable PSV

Group Type: EXPERIMENTAL

Variable PSV

Intervention Type: 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.

Conventional PSV

Group Type: ACTIVE_COMPARATOR

Conventional PSV

Intervention Type: 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.

Automated PSV

Group Type: ACTIVE_COMPARATOR

Automated PSV

Intervention Type: 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.

NAVA

Group Type: ACTIVE_COMPARATOR

NAVA

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Maria Vargas

Resercher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Naples

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Vargas

Role: CONTACT

vargas.maria82@gmail.com

+39 3396876440

Facility Contacts

maria vargas, MD

Role: primary

vargas.maria82@gmail.com

Other Identifiers

PSWEAN and EIT

Identifier Type: -

Identifier Source: org_study_id