Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.

Detailed Description
-----------------
After being informed about the study and potential risks, all parents or guardians giving written informed consent will be evaluate for study entry. Children in invasive mechanical ventilation who meet eligibility criteria will be submitted of two techniques of tracheal suctioning (with and without expiratory pause maneuver), randomized in a crossover trial in a 1:1 ratio, for determine the first technique to be applied. Clinical data will be collected (sex, age, presence of previous disease, diagnosis of hospitalization), as well as the ventilatory parameters (ventilation mode, peak inspiratory pressure, positive end-expiratory pressure, tidal volume, respiratory frequency, fraction of inspired oxygen). The protocol consists of an initial conventional tracheal suctioning with a negative pressure of 40mmHg for all the participants. After two (2) hours the first technique will be applied and an interval of another two hours for the application of the second technique. Respiratory mechanics and hemodynamic parameters will be evaluate before and after 30 minutes of each tracheal suctioning techniques. In case of clinical alterations that may aggravate the patients condition during the protocol (oxygen saturation < 85%, heart rate > 190bpm and/or decrease 20% of mean arterial blood pressure), the technique will be interrupted immediately and the patient will be evaluated.

Official Title
-----------------
Effects of Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children Submitted to Invasive Mechanical Ventilation: a Randomized Crossover Clinical Trial

Conditions
-----------------
Mechanical Ventilation Complication, Pediatric Respiratory Diseases

Intervention / Treatment
-----------------
* Other: Endotracheal suctioning with expiratory pause
* Other: Endotracheal suctioning without expiratory pause


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children at invasive mechanical ventilation for more than 24 hours; Under the effect of neuromuscular blocker (level of sedation assessed using the Comfort B Scale with a score <10 and without a cough reflex); Endotracheal suctioning in a period > 2h before the application of the technique. Exclusion Criteria: Patients with undrained pneumothorax or hemothorax, or presence of subcutaneous emphysema; Hemodynamic instability (hypotension refractory to treatment) Need of frequent endotracheal suctioning

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 2 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endotracheal suctioning without expiratory pause<br>Conventional endotracheal suctioning in closed suction system | Other: Endotracheal suctioning without expiratory pause<br>* Perform closed endotracheal suctioning without expiratory pause<br>|
| Experimental: Endotracheal suctioning with expiratory pause<br>Endotracheal suctioning in closed suction system associated with expiratory pause maneuver | Other: Endotracheal suctioning with expiratory pause<br>* Perform closed endotracheal suctioning with an expiratory pause of 5 seconds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight of endotracheal suctioning | Weight of endotracheal suctioning in milligrams | Immediately after suctioning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak inspiratory pressure | Peak inspiratory pressure in centimeters of water (cmH2O) | Baseline and 30 minutes | 
| Plateau pressure | Plateau pressure in centimeters of water (cmH2O) | Baseline and 30 minutes | 
| Tidal volume | Tidal volume in milliliters (ml) | Baseline and 30 minutes | 
| Dynamic compliance | Dynamic compliance in milliliters per kilograms per centimeters of water (mL/kg/cmH2O) | Baseline and 30 minutes | 
| Airway resistance | Inspiratory and expiratory resistance in centimeters of water per liter (cmH2O/L) | Baseline and 30 minutes | 
| Auto-positive end-expiratory pressure (auto-PEEP) | Auto-PEEP in centimeters of water (cmH2O) | Baseline and 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric Critical Care, Respiratory Mechanics, Tracheal Suctioning, Mechanical ventilation