PAV Trial During SBT Trial

Lung Mechanics Assessment During Extubation Trial in Critical Ill Patients

Weaning from mechanical ventilation is milestone in intensive care unit. The prolongation of mechanical ventilatory support is associated with contractility disorders of the diaphragm muscle as well as an increase in the incidence of nosocomial pneumonia. On the other hand, an early interruption of mechanical ventilatory support could be associate with the onset of acute respiratory failure, pulmonary edema, hemodynamic instability and the increased risk of re-intubation. Therefore, careful analysis of surrogate clinical parameters is essential in understanding "when" the critically ill patient is really ready for a complete weaning from mechanical ventilatory support. To date, the physician is invited to examine various clinical parameters predicting the success of extubation, such as hemodynamic stability, metabolic structure and the patient's state of consciousness. In addition, various surrogate ventilatory parameters help the clinician to understand the patient's degree of autonomy in the spontaneous breathing process, such as alveolar exchange, as well as the degree of ventilatory performance through the analysis of ventilatory parameters that can be evaluated during assisted mechanical ventilation. To date, the use of proportional assisted ventilation methods such as Proportional Assisted Ventilation + (PAV +) allow us to continuously evaluate the mechanical characteristics of the respiratory system as well as the respiratory work that the patient sustains breath by breath.

The objective of this study is to evaluate whether the ventilatory parameters derived from the PAV ventilatory algorithm are also predictors of extubation success.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Complication

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Francesco Murgolo; Phone Number: +39 0805592873; Email: Francesco.murgolo@uniba.it

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Azienda Ospedaliero Universitaria Policlinico
    • Contact: Salvatore Grasso, Prof; Phone Number: 0039 347 3630073; Email: salvatore.grasso@uniba.it
  • Bari, Italy, 70124
    • Recruiting
    • Salvatore Grasso
    • Contact: SALVATORE GRASSO; Email: SALVATORE.GRASSO@UNIBA.IT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• Hypoxemic patients (PaO2/FiO2 < 300 mmHg)
• patients who have received invasive mechanical ventilation for at least 48 hours
• Patients who have win conventional criteria for extubation ( spontaneous breathing trial)

Description

Inclusion Criteria:

• Hypoxemic patients (PaO2/FiO2 < 300 mmHg)
• patients who have received invasive mechanical ventilation for at least 48 hours
• Patients who have win conventional criteria for extubation ( spontaneous breathing trial)

Exclusion Criteria:

• hemodynamic instability
• Neuromuscular disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the aims of this study is assess all physiological variables that define the patient's breathing pattern in patients undergoing spontaneous breathing trial before extubation.	In this study will be assess the pulmonary characteristics of the respiratory system. The main outcome is the assessment of patient work of breathing (J/L) during SBT trial before extubation. The work of breathing will be recorded directly by the pulmonary ventilator.	48 hours

Collaborators and Investigators

• Sponsor: University of Bari
• Collaborators: Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SBT_PAV01

Drug and device information, study documents

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