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Clinical Trials/NCT03962322
NCT03962322
Completed
Not Applicable

Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Azienda Ospedaliero Universitaria Maggiore della Carita1 site in 1 country100 target enrollmentMay 27, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weaning From Mechanical Ventilation
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Enrollment
100
Locations
1
Primary Endpoint
Primary Outcome Measure - Change in diaphragmatic displacement velocity
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 27, 2019
End Date
November 29, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Responsible Party
Principal Investigator
Principal Investigator

Gianmaria Cammarota

Principal Investigator, MD of ICU staff

Azienda Ospedaliero Universitaria Maggiore della Carita

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

Outcomes

Primary Outcomes

Primary Outcome Measure - Change in diaphragmatic displacement velocity

Time Frame: through each trial completion, an average of 20 minutes

Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial ( CPAP 5 ) and in spontaneous breathing.

Secondary Outcomes

  • 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)

Study Sites (1)

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