PAV Trial During SBT Trial

Mechanical Ventilation Complication Clinical Trial

Official title:

Lung Mechanics Assessment During Extubation Trial in Critical Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295186
• Other study ID #: SBT_PAV01
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2024
• Source: University of Bari
• Contact: Francesco Murgolo
• Phone: +39 0805592873
• Email: Francesco.murgolo[@]uniba.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Policlinico	Bari
Italy	Salvatore Grasso	Bari

Sponsors (2)

Lead Sponsor	Collaborator
University of Bari	Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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