Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics Randomized, Crossover Clinical Study

Study Overview
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Brief Summary
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Introduction: Patients on mechanical ventilation suffer alterations in the viscoelastic characteristics of the mucus due to changes in the humidity and temperature of the inhaled air and in the respiratory volumes and flows. The literature has pointed out the use of mechanical ventilators as a tool for mobilizing secretions and closed-system aspiration associated with expiratory pause has been shown to be effective in mobilizing secretions. Objectives: To assess whether there is a difference in the mass of aspirated secretion with the application of the expiratory pause during aspiration. Methods: A crossover, randomized study. Applied to children aged 0 to 5 years and 11 months who are intubated for 24 hours with orotracheal tubes or tracheostomy. There will be an exclusion of patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study. The technique will be during aspiration in the tube with where to apply or not the expiratory pause on the mechanical ventilator. This secretion will be weighed so that there is fidelity in the results.

Detailed Description
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A prospective, crossover, randomized clinical study will be carried out in the Pediatric ICU of Hospital Israelite Albert Einstein.

Official Title
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Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics: A Randomized, Crossover Clinical Study

Conditions
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Respiratory Insufficiency in Children

Intervention / Treatment
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* Other: with pause- without pause
* Other: without pause-with pause


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 0 to 5 years and 11 months who have been on invasive mechanical ventilation for more than 24 hours through an orotracheal cannula or tracheostomy will be included in the study. Exclusion Criteria: Patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study will be excluded from the study.

Ages Eligible for Study
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Maximum Age: 5 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients who meet the inclusion criteria and after signing the informed consent by the guardian will be randomized to closed system aspiration with an expiratory pause and closed system aspiration without an expiratory pause. Randomization will be performed by blocks of sealed envelopes, allocating the patient to a first technique to be performed and, after 6 hours, to another technique. All patients will perform both forms of aspiration and will be aspirated 2 hours before the start of each technique to match the groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with pause- without pause<br>Start with an expiratory pause during aspiration and after 6hours the aspiration is performed without an expiratory pause | Other: with pause- without pause<br>* start with pause expiration<br>|
| Active Comparator: without pause - with pause<br>Start without an expiratory pause during aspiration and after 6hours the aspiration is performed with an expiratory pause | Other: without pause-with pause<br>* start without pause expiration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secretion mass | The secretion will be weighed on a scale graduated in milligrams. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tidal volume | tidal volume checked on the mechanical ventilator graduated in ml | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Insufficiency, respiratory artificial