- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03962322
Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation (TDD-wean)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Novara, Italy, 28100
- A.O.U Maggiore della Carità
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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
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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.
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through each trial completion, an average of 20 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragmatic acceleration and deceleration
Time Frame: through each trial completion, an average of 20 minutes
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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.
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through each trial completion, an average of 20 minutes
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Gas exchange - arterial carbon dioxide tension
Time Frame: through each trial completion, an average of 20 minutes
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Arterial blood gases sample
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through each trial completion, an average of 20 minutes
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Gas exchange - pH
Time Frame: through each trial completion, an average of 20 minutes
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Arterial blood gases sample
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through each trial completion, an average of 20 minutes
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Gas exchange - arterial oxygen tension
Time Frame: through each trial completion, an average of 20 min
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Arterial blood gases sample
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through each trial completion, an average of 20 min
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Dyspnea level
Time Frame: through each trial completion, an average of 20 minutes
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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.
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through each trial completion, an average of 20 minutes
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Heart rate
Time Frame: through each trial completion, an average of 20 minutes
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Heart Rate (HR) averages during each of the 3 ventilatory modes
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through each trial completion, an average of 20 minutes
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Number of patients who experienced weaning failure
Time Frame: over 48 hours following extubation
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the need for non invasive ventilation or re-intubation due to any cause
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over 48 hours following extubation
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Blood Pressure
Time Frame: through each trial completion, an average of 20 minutes
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Mean arterial Blood Pressure (BP) averages during each of the 3 ventilatory modes
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through each trial completion, an average of 20 minutes
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Collaborators and Investigators
Publications and helpful links
General Publications
- Tobin MJ. Respiratory monitoring in the intensive care unit. Am Rev Respir Dis. 1988 Dec;138(6):1625-42. doi: 10.1164/ajrccm/138.6.1625.
- Cammarota G, Boniolo E, Santangelo E, De Vita N, Verdina F, Crudo S, Sguazzotti I, Perucca R, Messina A, Zanoni M, Azzolina D, Navalesi P, Longhini F, Vetrugno L, Bignami E, Della Corte F, Tarquini R, De Robertis E, Vaschetto R. Diaphragmatic Kinetics Assessment by Tissue Doppler Imaging and Extubation Outcome. Respir Care. 2021 Jun;66(6):983-993. doi: 10.4187/respcare.08702. Epub 2021 Apr 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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