Non Invasive Mechanical Ventilation VERSUS Oxygen MASK

NCT ID: NCT03259854

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-09-01

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

Conditions

Mechanical Ventilation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

oxygen mask

Intervention Type: DEVICE

use of oxygen mask after successful weaning from invasive mechanical ventilation

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

Group Type: EXPERIMENTAL

non invasive mechanical ventilation in pediatrics

Intervention Type: DEVICE

use of non invasive mechanical ventilation in pediatrics after successful weaning from invasive mechanical ventilation

Interventions

non invasive mechanical ventilation in pediatrics

use of non invasive mechanical ventilation in pediatrics after successful weaning from invasive mechanical ventilation

Intervention Type: DEVICE

oxygen mask

use of oxygen mask after successful weaning from invasive mechanical ventilation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Khalaf

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Maher Mokhtar, professor

Role: CONTACT

maher61ahmed@yahoo.com

00201066006605

mohamed amer fathy, professor

Role: CONTACT

00201005689353

References

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.

Reference Type: RESULT

PMID: 19682735 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15857531 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18416851 (View on PubMed)

Other Identifiers

NVM

Identifier Type: -

Identifier Source: org_study_id