Non Invasive Mechanical Ventilation VERSUS Oxygen MASK

Not Applicable

• Conditions: Mechanical Ventilation Complication
• Interventions: Device: non invasive mechanical ventilation in pediatrics; Device: oxygen mask

• Registration Number: NCT03259854
• Lead Sponsor: Assiut University

Brief Summary

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

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

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-13
• Study First Submitted QC: 2017-08-21
• Last Update Submitted: 2017-08-21
• Study First Posted: 2017-08-24
• Last Update Posted: 2017-08-24
• Study Start: 2017-09-01
• Primary Completion: 2018-09-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

all the patients with successful weaning from invasive mechanical ventilation

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Exclusion Criteria

1. Maxillofacial trauma
2. Gastrointestinal obstruction
3. Severe lung secretion
4. Irreversible organ failure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non invasive ventilation study group	non invasive mechanical ventilation in pediatrics	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
oxygen mask control group	oxygen mask	patients will receive oxygen by mask will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases

Primary Outcome Measures

Name	Time	Method
risk of respiratory failure after non invasive ventilation use	one week after successful weaning from invasive mechanical ventilation	The patients will be evaluated to determine any manifestation of respiratory failure

Secondary Outcome Measures

Name	Time	Method
complications of non invasive mechanical ventilation in pediatrics	one week after use of non invasive ventilation	monitor any complications from use of Non Invasive Ventilation
length of hospital stay after non invasive ventilation use	one month after use of non invasive ventilation	the duration of hospital stay for all patients will be recorded