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

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ClinicalTrials.gov Identifier: NCT03962322
Recruitment Status : Completed
First Posted : May 24, 2019
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weaning From Mechanical Ventilation Other: Weaning TDI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation
Actual Study Start Date : May 27, 2019
Actual Primary Completion Date : November 29, 2019
Actual Study Completion Date : November 29, 2019
Arms and Interventions
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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.
 Other: Weaning TDI

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Gas exchange - arterial carbon dioxide tension [ Time Frame: through each trial completion, an average of 20 minutes ]
    Arterial blood gases sample

  3. Gas exchange - pH [ Time Frame: through each trial completion, an average of 20 minutes ]
    Arterial blood gases sample

  4. Gas exchange - arterial oxygen tension [ Time Frame: through each trial completion, an average of 20 min ]
    Arterial blood gases sample

  5. 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.

  6. Heart rate [ Time Frame: through each trial completion, an average of 20 minutes ]
    Heart Rate (HR) averages during each of the 3 ventilatory modes

  7. 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

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962322


Locations
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Italy
A.O.U Maggiore della Carità
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gianmaria Cammarota, Principal Investigator, MD of ICU staff, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT03962322    
Other Study ID Numbers: CE 23/19
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita:
Diaphragmatic Tissue Doppler
Weaning
Mechanical ventilation