Non Invasive Mechanical Ventilation VERSUS Oxygen MASK

Study Overview
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Brief Summary
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Conventional mechanical ventilation is a core feature of intensive care. Weaning and removal of endotracheal tube are crucial processes, which often account for a considerable part of Conventional mechanical ventilation total time. Unsuccessful extubation has been noted to be associated with an increase of both morbidity and mortality in adult and pediatric patients

Detailed Description
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The documented rate of failed extubations ranges from 4.1 to 14% in pediatric intensive care units.Therefore, strategies preventing the need for reintubation are needed. Non invasive ventilation has been proposed as useful therapy to wean patients after unsuccessful weaning trials and to avoid reintubation in adults, though controversy exists at this concern. This technique is increasingly being used in pediatric patients over the last years. The objective of the present study was to determine post extubation Non invasive ventilation characteristics and to identify risk factors of post extubation Non invasive ventilation failure in children

Official Title
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Non Invasive Mechanical Ventilation VERSUS Oxygen MASK After Successful Weaning From Invasive Mechanical Ventilation in Pediatrics

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Device: non invasive mechanical ventilation in pediatrics
* Device: oxygen mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all the patients with successful weaning from invasive mechanical ventilation Exclusion Criteria: Maxillofacial trauma Gastrointestinal obstruction Severe lung secretion Irreversible organ failure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxygen mask control group<br>patients will receive oxygen by mask will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases | Device: oxygen mask<br>* use of oxygen mask after successful weaning from invasive mechanical ventilation<br>|
| Experimental: non invasive ventilation study group<br>patients will receive non invasive ventilation after successful weaning from invasive ventilation and will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases | Device: non invasive mechanical ventilation in pediatrics<br>* use of non invasive mechanical ventilation in pediatrics after successful weaning from invasive mechanical ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of respiratory failure after non invasive ventilation use | The patients will be evaluated to determine any manifestation of respiratory failure | one week after successful weaning from invasive mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of non invasive mechanical ventilation in pediatrics | monitor any complications from use of Non Invasive Ventilation | one week after use of non invasive ventilation | 
| length of hospital stay after non invasive ventilation use | the duration of hospital stay for all patients will be recorded | one month after use of non invasive ventilation |