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Non Invasive Mechanical Ventilation VERSUS Oxygen MASK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259854
Recruitment Status : Unknown
Verified August 2017 by Mohamed Khalaf, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Khalaf, 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

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Device: non invasive mechanical ventilation in pediatrics Device: oxygen mask Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Non Invasive Mechanical Ventilation VERSUS Oxygen MASK After Successful Weaning From Invasive Mechanical Ventilation in Pediatrics
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. risk of respiratory failure after non invasive ventilation use [ Time Frame: one week after successful weaning from invasive mechanical ventilation ]
    The patients will be evaluated to determine any manifestation of respiratory failure


Secondary Outcome Measures :
  1. complications of non invasive mechanical ventilation in pediatrics [ Time Frame: one week after use of non invasive ventilation ]
    monitor any complications from use of Non Invasive Ventilation

  2. length of hospital stay after non invasive ventilation use [ Time Frame: one month after use of non invasive ventilation ]
    the duration of hospital stay for all patients will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259854


Contacts
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Contact: Maher Mokhtar, professor 00201066006605 maher61ahmed@yahoo.com
Contact: mohamed amer fathy, professor 00201005689353

Sponsors and Collaborators
Assiut University
Publications of Results:
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Responsible Party: Mohamed Khalaf, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03259854    
Other Study ID Numbers: NVM
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No