Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.

Study Overview
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Brief Summary
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The aim of the present investigation will be to evaluate diaphragmatic excursion velocity during non-invasive ventilation and spontaneous breathing at both inspiration and expiration. this analysis will be performed through diaphragmatic tissue Doppler assessment.

Detailed Description
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Early weaning from invasive ventilation, in patients admitted to intensive care, is associated with a marked reduction in ventilator-associated pneumonia, length of stay in intensive care unit and hospital, total duration of mechanical ventilation and decrease in overall mortality. Moreover, in case of need of protected extubation, non-invasive ventilation has allowed to prevent re-intubation and decrease hospital mortality compared to the simple administration of oxygen through a facial mask, in particular when applied immediately after extubation. The diaphragmatic tissue doppler imaging (TDI) is an ultrasonographic technique derived from ultrasound evaluation of the heart's motility. It can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive. The aim of the study is the evaluation of the diaphragmatic excursion velocity variations using diaphragmatic tissue doppler, measured in venturi mask and non-invasive ventilation in the post-extubation period, in order to compare the diaphragm stress variations during the two different modes. Method Patients after extubation will be randomly submitted to a spontaneous breathing test in venturi mask and in facemask or helmet NIV. Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragm examination will be performed to assess the speed speed of muscle displacement, acceleration and deceleration. Inclusion criteria: invasive mechanical ventilation > 24h with consequent extubation. Exclusion criteria: refusal to grant consent, pregnancy, age < 18 years, haemodynamic instability, difficult management of secretions, required inotropic and / or vasoactive drugs at high doses. During the study, vital parameters will be given.

Official Title
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Diaphragm Performance Evaluation With Tissue Doppler Ultrasound Examination During Spontaneous Breathing in Facial Mask and During Non-invasive Ventilation in the Post-extubation Period.

Conditions
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Acute Respiratory Failure, Non-invasive Ventilation

Intervention / Treatment
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* Other: Post-extubation TDI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: invasive mechanical ventilation > 24h with consequent extubation Exclusion Criteria: refusal to grant consent pregnancy age >18 years haemodynamic instability difficult management of secretions required inotropic and / or vasoactive drugs at high doses

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diaphragmatic tissue doppler evaluation<br>A tissue Doppler evaluation, using a sectorial probe, will be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration randomly assessed in spontaneous breathing with Venturi Mask and in Non-invasive ventilation with a helmet or facial mask | Other: Post-extubation TDI<br>* A diaphragmatic tissue Doppler evaluation will be performed during non-invasive ventilation and spontaneous breathing trial applied in random sequence. Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragmatic examination will be performed to assess the speed of diaphragmatic displacement during inspiration and expiration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diaphragmatic displacement velocity | Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask. | through each trial completion, an average of 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic acceleration | Inspiratory and expiratory diaphragmatic displacement acceleration evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask. | through each trial completion, an average of 20 minutes | 
| Gas exchange - arterial carbon dioxide tension | PaCO2, will be obtained performing ABG sample | through each trial completion, an average of 20 minutes | 
| Gas exchange - pH | pH will be obtained performing ABGs. | through each trial completion, an average of 20 minutes | 
| Gas exchange - arterial oxygen tension | arterial oxygenation PaO2 will be obtained performing ABGs. | through each trial completion, an average of 20 minutes | 
| Dyspnea level | dyspnea level evaluated through visual analogical scale ( VAS dyspnea) | through each trial completion, an average of 20 minutes | 
| Comfort level | Comfort level evaluated through Comfort Scale | through each trial completion, an average of 20 minutes | 
| Hemodynamic parameters, Heart Rate (HR) | Heart Rate (HR) | athrough each trial completion, an average of 20 minutes | 
| Blood Pressure (BP) | invasive Mean arterial Blood Pressure | through each trial completion, an average of 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragmatic Tissue Doppler, Non invasive ventilation, Spontaneous breathing, Post-extubation