Non Invasive Mechanical Ventilation VERSUS Oxygen MASK

NCT03259854 | Unknown

• 1 other identifier: NVM
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• complications of non invasive mechanical ventilation in pediatrics

  one week after use of non invasive ventilation

• length of hospital stay after non invasive ventilation use

  one month after use of non invasive ventilation

Study Arms (2)

oxygen mask control group

ACTIVE COMPARATOR

patients will receive oxygen by mask will be monitored regarding oxygen saturation, blood pressure, respiratory rate, heart rate, arterial blood gases

Device: oxygen mask

non invasive ventilation study group

EXPERIMENTAL

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

Interventions

non invasive mechanical ventilation in pediatrics DEVICE

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

non invasive ventilation study group

oxygen mask DEVICE

use of oxygen mask after successful weaning from invasive mechanical ventilation

oxygen mask control group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all the patients with successful weaning from invasive mechanical ventilation

You may not qualify if:

• Maxillofacial trauma
• Gastrointestinal obstruction
• Severe lung secretion
• Irreversible organ failure

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 19682735 RESULT

• 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.

  PMID: 15857531 RESULT

• 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.

  PMID: 18416851 RESULT

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Maher Mokhtar, professor

CONTACT

00201066006605; maher61ahmed@yahoo.com

mohamed amer fathy, professor

CONTACT

00201005689353

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 13, 2017
• First Posted: August 24, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: August 24, 2017

Record last verified: 2017-08