Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Sponsors

Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Source Azienda Ospedaliero Universitaria Maggiore della Carita
Brief Summary

Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.

Detailed Description

Tobin Index (RSBI), which is the ratio between respiratory rate (RR) and tidal volume (VT), is one of the most used indices to predict weaning outcome. The diaphragm plays a key role in generating VT and, in the case of diaphragmatic dysfunction, inspiratory accessory muscles may contribute to support ventilation. If this occurs during a spontaneous breathing trial (SBT), it will probably result in delayed weaning, since the accessory muscles are more fatigable than the diaphragm.

The diaphragmatic tissue Doppler imaging (TDI) is an ultrasonographic technique derived from ultrasound evaluation of heart's motility. Being a muscle doppler assessment, it can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive, as well as other derived index of muscle function.

The aim of the study is to measure the variations of diaphragmatic displacement velocities before and during the spontaneous breathing trial, useful to check if the patient is ready to breathe spontaneously. An observational study will be performed. Patients who are ready to be weaned will be subjected to a spontaneous breathing test (Cpap 5), that consists of applying a positive end-expiratory pressure of 5 cm H2O for 20 minutes. A tissue Doppler evaluation will then be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration in the modality of ventilation which precedes the trial and during the SBT.

Vital parameters will be monitored during the study. Mechanical ventilation length, incidence of tracheostomies, ICU and hospital recovery duration and hospital mortality will also be acquired.

Overall Status Completed
Start Date May 27, 2019
Completion Date November 29, 2019
Primary Completion Date November 29, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary Outcome Measure - Change in diaphragmatic displacement velocity through each trial completion, an average of 20 minutes
Secondary Outcome
Measure Time Frame
Diaphragmatic acceleration and deceleration through each trial completion, an average of 20 minutes
Gas exchange - arterial carbon dioxide tension through each trial completion, an average of 20 minutes
Gas exchange - pH through each trial completion, an average of 20 minutes
Gas exchange - arterial oxygen tension through each trial completion, an average of 20 min
Dyspnea level through each trial completion, an average of 20 minutes
Heart rate through each trial completion, an average of 20 minutes
Number of patients who experienced weaning failure over 48 hours following extubation
Blood Pressure through each trial completion, an average of 20 minutes
Enrollment 100
Condition
Intervention

Intervention Type: Other

Intervention Name: Weaning TDI

Description: Patients will be subjected to a spontaneous breathing test (Cpap 5), that consists in applying a positive end-expiratory pressure of 5 cm H2O for 20 minutes. A tissue doppler evaluation will then be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration and calculating the speed of muscles displacement and other derived index of muscle function in the modality of ventilation which precedes the trial, during the SBT and after extubation.

Arm Group Label: Weaning TDI

Eligibility

Criteria:

Inclusion Criteria:

- mechanical invasive ventilation ≥ 24 h

- readiness for extubation

Exclusion Criteria:

- refusal to grant consent

- pregnancy

- hemodynamic instability

- difficult management of secretions

- request for inotropy and/or vasoactive drugs at high doses

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: A.O.U Maggiore della Carità
Location Countries

Italy

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita

Investigator Full Name: Gianmaria Cammarota

Investigator Title: Principal Investigator, MD of ICU staff

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Weaning TDI

Type: Experimental

Description: A tissue doppler evaluation, using a sector transducer, will be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration in the modality of ventilation which precedes the trial, during the SBT and after extubation.

Acronym TDD-wean
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov