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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03259854
Other study ID # NVM
Secondary ID
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
Health authority
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

Study Design


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
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