Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning

Study Overview
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Brief Summary
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Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.

Detailed Description
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Endotracheal aspiration is a very useful procedure. It has several adverse events every time that aspiration is practiced. This trials wants to identify which protocol (necessity versus routine) could be better to practice in pediatrics intensive care unit with less risk.

Official Title
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Differences in Morbidity Frequency Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning Protocol in Hospital Pablo Tobon Uribe´s Pediatric Intensive Care Unit (PICU). A Randomized Controlled Trial

Conditions
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Hypoxemia, Arrhythmias, Cardiac Arrest, Ventilator Associated Pneumonia

Intervention / Treatment
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* Procedure: Necessity endotracheal suctioning
* Procedure: Routine endotracheal suctioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children older than 1 month until 14 years old requiring orotracheal intubation Exclusion Criteria: High frequency ventilation mode

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 14 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Necessity endotracheal suctioning<br>Endotracheal suctioning depends on clinical manifestations | Procedure: Necessity endotracheal suctioning<br>* Endotracheal suctioning depends on clinical manifestations<br>|
| Other: Routine endotracheal suctioning<br>Endotracheal suctioning every two hours | Procedure: Routine endotracheal suctioning<br>* Endotracheal suctioning every two hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Composite End Point | All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician. | Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical Ventilation Length as Days. | Number of days under mechanical ventilation during ICU hospitalization length | Every day while patient really is intubated. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unplanned extubation, Length of stay in PICU, Length of mechanical ventilation