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Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03962322
Acronym
TDD-wean
Enrollment
100
Registered
2019-05-24
Start date
2019-05-27
Completion date
2019-11-29
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weaning From Mechanical Ventilation

Keywords

Diaphragmatic Tissue Doppler, Weaning, Mechanical ventilation

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.

Interventions

OTHERWeaning 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.

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single Group Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome Measure - Change in diaphragmatic displacement velocitythrough each trial completion, an average of 20 minutesInspiratory 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

MeasureTime frameDescription
Gas exchange - arterial carbon dioxide tensionthrough each trial completion, an average of 20 minutesArterial blood gases sample
Gas exchange - pHthrough each trial completion, an average of 20 minutesArterial blood gases sample
Gas exchange - arterial oxygen tensionthrough each trial completion, an average of 20 minArterial blood gases sample
Diaphragmatic acceleration and decelerationthrough each trial completion, an average of 20 minutesDiaphragmatic 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.
Heart ratethrough each trial completion, an average of 20 minutesHeart Rate (HR) averages during each of the 3 ventilatory modes
Number of patients who experienced weaning failureover 48 hours following extubationthe need for non invasive ventilation or re-intubation due to any cause
Blood Pressurethrough each trial completion, an average of 20 minutesMean arterial Blood Pressure (BP) averages during each of the 3 ventilatory modes
Dyspnea levelthrough each trial completion, an average of 20 minutesDyspnea 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026