Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation (TDD-wean)

April 27, 2020 updated by: Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita
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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Novara, Italy, 28100
        • A.O.U Maggiore della Carità

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weaning TDI
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through each trial completion, an average of 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragmatic acceleration and deceleration
Time Frame: through each trial completion, an average of 20 minutes
Diaphragmatic acceleration and deceleration evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial ( CPAP 5 ) and in spontaneous breathing.
through each trial completion, an average of 20 minutes
Gas exchange - arterial carbon dioxide tension
Time Frame: through each trial completion, an average of 20 minutes
Arterial blood gases sample
through each trial completion, an average of 20 minutes
Gas exchange - pH
Time Frame: through each trial completion, an average of 20 minutes
Arterial blood gases sample
through each trial completion, an average of 20 minutes
Gas exchange - arterial oxygen tension
Time Frame: through each trial completion, an average of 20 min
Arterial blood gases sample
through each trial completion, an average of 20 min
Dyspnea level
Time Frame: through each trial completion, an average of 20 minutes
Dyspnea level will be evaluated through visual analogical scale ( VAS dyspnea). The dyspnea visual analog scale is represented by a 20 cm horizontal line. The ends are defined as the extreme limits of dyspnea from the left-lower end best, "not at all breathless"-to the right-upper end worst, "extremely breathless". Subjects will be instructed to indicate on the line the point corresponding to their breathlessness perception.
through each trial completion, an average of 20 minutes
Heart rate
Time Frame: through each trial completion, an average of 20 minutes
Heart Rate (HR) averages during each of the 3 ventilatory modes
through each trial completion, an average of 20 minutes
Number of patients who experienced weaning failure
Time Frame: over 48 hours following extubation
the need for non invasive ventilation or re-intubation due to any cause
over 48 hours following extubation
Blood Pressure
Time Frame: through each trial completion, an average of 20 minutes
Mean arterial Blood Pressure (BP) averages during each of the 3 ventilatory modes
through each trial completion, an average of 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

November 29, 2019

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CE 23/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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