PAV Trial During SBT Trial

Sponsor

University of Bari (Other)

Overall Status

Recruiting

CT.gov ID

NCT05295186

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation Complication

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Lung Mechanics Assessment During Extubation Trial in Critical Ill Patients

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Outcome Measures

Primary Outcome Measures

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. [48 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

start of mechanical ventilation 48 hours

Exclusion Criteria:

hemodynamic instability
Neuromuscular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliero Universitaria Policlinico	Bari		Italy	70124
2	Salvatore Grasso	Bari		Italy	70124

Sponsors and Collaborators

University of Bari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Salvatore Grasso, PROF, University of Bari

ClinicalTrials.gov Identifier:

NCT05295186

Other Study ID Numbers:

SBT_PAV01

First Posted:

Mar 25, 2022

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 25, 2022