Non Invasive Mechanical Ventilation VERSUS Oxygen MASK

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03259854
• Other study ID #: NVM
• Status: Not yet recruiting
• Phase: N/A
• First received: August 13, 2017
• Last updated: August 21, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Maher Mokhtar, professor
• Phone: 00201066006605
• Email: maher61ahmed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• non invasive mechanical ventilation in pediatrics
use of non invasive mechanical ventilation in pediatrics after successful weaning from invasive mechanical ventilation
• oxygen mask
use of oxygen mask after successful weaning from invasive mechanical ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

Ferrer M, Sellarés 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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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