Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Weaning From Mechanical Ventilation Clinical Trial

— TDD-wean  

Official title:

Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962322
• Other study ID #: CE 23/19
• Status: Completed
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: April 2020
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weaning From Mechanical Ventilation

Intervention

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.

Locations

Country	Name	City	State
Italy	A.O.U Maggiore della Carità	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Tobin MJ. Respiratory monitoring in the intensive care unit. Am Rev Respir Dis. 1988 Dec;138(6):1625-42. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure - Change in diaphragmatic displacement velocity	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	Diaphragmatic acceleration and deceleration	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
Secondary	Gas exchange - arterial carbon dioxide tension	Arterial blood gases sample	through each trial completion, an average of 20 minutes
Secondary	Gas exchange - pH	Arterial blood gases sample	through each trial completion, an average of 20 minutes
Secondary	Gas exchange - arterial oxygen tension	Arterial blood gases sample	through each trial completion, an average of 20 min
Secondary	Dyspnea level	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
Secondary	Heart rate	Heart Rate (HR) averages during each of the 3 ventilatory modes	through each trial completion, an average of 20 minutes
Secondary	Number of patients who experienced weaning failure	the need for non invasive ventilation or re-intubation due to any cause	over 48 hours following extubation
Secondary	Blood Pressure	Mean arterial Blood Pressure (BP) averages during each of the 3 ventilatory modes	through each trial completion, an average of 20 minutes