Ventilatory Weaning Guided by a New Index

Study Overview
=================
Brief Summary
-----------------
Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory failure. The ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. In this sense, indices that can predict successful weaning are of great value.

Detailed Description
-----------------
Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory failure. The ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. In this sense, indices that can predict successful weaning are of great value. Our study aimed to evaluate the performance of a new ventilatory weaning index, the timed inspiratory effort index (TIE index), as a weaning predictor in comparison with the traditionally used spontaneous breathing test (SBT). The study is a randomized controlled trial of a cohort of mechanically ventilated patients over 24 hours admitted to the ICU of Hospital e Clínica São Gonçalo (HCSG), located in the city of São Gonçalo, State of Rio de Janeiro, Brazil. The TIE index is calculated as the ratio of the maximum inspiratory pressure developed in the last 30 seconds of a 60 second period of unidirectional airway occlusion by the time required to reach this value.

Official Title
-----------------
Ventilatory Weaning Guided by the Timed Inspiratory Effort Index

Conditions
-----------------
Respiration, Artificial

Intervention / Treatment
-----------------
* Device: Timed Inspiratory Effort (TIE index)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion and exclusion criteria Our study included patients over 18 years old, under mechanical ventilation, who remained for more than 24 hours of invasive ventilatory assistance and who were able to start the process of weaning. Exclusion criteria comprised tracheostomy, chronic neurological disorders, low level of alertness, and chronic immune suppression states, including positive serology for HIV.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Interventions: Control<br>Conventional clinical treatment and using the ventilatory weaning protocol and standard extubation with the spontaneous breathing test (SBT) with the T-piece in 30 minutes. | |
| Experimental: Experimental: Intervention<br>Conventional clinical treatment and using the Timed Inspiratory Effort (TIE index), which guided the decision to ventilate weaning and extubation. | Device: Timed Inspiratory Effort (TIE index)<br>* Conventional clinical treatment and using the Timed Inspiratory Effort (TIE index), which guided the decision to ventilate weaning and extubation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sucessful weaning | Compare the timed inspiratory effort index parameter TIE as an indicator of weaning compared to the spontaneous breathing test | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of failure at weaning | Compare the frequency of failure at weaning when using the TIE index or the T-piece TRE as a criterion for extubation. | Two years | 
| Counting of the number of tests needed until extubation | Evaluate the number of tests required until the decision favorable to extubation was made in both groups. | Two years | 
| Comparison of the length of stay in the ICU | Compare the length of stay in the ICU between extubation, discharge or death counted from extubation among patients who used the TIE or SBT index in T piece. | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical Ventilator, Ventilator Weaning, Spontaneous Breath Test, Predictive Index