Non Invasive Mechanical Ventilation VERSUS Oxygen MASK

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

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

Study Overview

• Status: Unknown
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Device: oxygen mask; Device: non invasive mechanical ventilation in pediatrics

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 Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maher Mokhtar, professor; Phone Number: 00201066006605; Email: maher61ahmed@yahoo.com
• Study Contact Backup: Name: mohamed amer fathy, professor; Phone Number: 00201005689353

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

all the patients with successful weaning from invasive mechanical ventilation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: oxygen mask control group; patients will receive oxygen by mask will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases	Device: oxygen mask; use of oxygen mask after successful weaning from invasive mechanical ventilation
EXPERIMENTAL: non invasive ventilation study group; 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; use of non invasive mechanical ventilation in pediatrics after successful weaning from invasive mechanical ventilation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
• Baisch SD, Wheeler WB, Kurachek SC, Cornfield DN. Extubation failure in pediatric intensive care incidence and outcomes. Pediatr Crit Care Med. 2005 May;6(3):312-8. doi: 10.1097/01.PCC.0000161119.05076.91.
• Trevisan CE, Vieira SR; Research Group in Mechanical Ventilation Weaning. Noninvasive mechanical ventilation may be useful in treating patients who fail weaning from invasive mechanical ventilation: a randomized clinical trial. Crit Care. 2008;12(2):R51. doi: 10.1186/cc6870. Epub 2008 Apr 17.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: August 13, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (ACTUAL): August 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NVM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No