A Multicentered Study on Efficiency of Noninvasive Ventilation Procedures

NCT03066934 | Completed DMC

• 1 other identifier: 70904504/525
• Study Type: observational
• Target: 352
• Locations: 1 country
• Sites: 2

Brief Summary

Noninvasive ventilation (NIV) is an alternative form of ventilatory support in critical care encompassing different modes of ventilation such as continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) and high flow nasal cannula ventilation. Although numerous studies on adults exit in literature, the aspects of this ventilatory support is limited in pediatric age groups. Early recognition of respiratory failure and initiation of NIV in a pediatric patient would positively affect prognosis by avoiding certain complications of endotracheal intubation and mechanical ventilation and adds certain advantages. Decreasing re-intubation rates for the ones who are extubated but necessitating further oxygen support is another advantage of NIV. Although numerous studies on adults exit in literature, the aspects of this ventilatory support is limited in pediatric age groups. Besides, success as well as failure and complication rates in pediatric age groups vary extensively. This multi-centered, prospective cohort study is planned to observe the epidemiologic perspectives of study group within underlying problems, success rates between different age groups, complication and re-intubation rates and finally its' effect on prognosis and long term survival in a year period. Hence we believe results of this study would allow us to improve our knowledge on using this technique, applying different modes and parameters appropriately and design criteria to guide clinician in deciding which group of patients would benefit from NIV techniques.

Conditions

Noninvasive Positive Pressure Ventilation; High Flow Nasal Cannula; Failure, Respiratory

Keywords

Noninvasive Positive Pressure Ventilation; Nasal high flow; Respiratory Failure; Childhood

Outcome Measures

Primary Outcomes (2)

• To determine the incidence of NIV failure in children requiring invasive mechanical ventilation

  NIV failure is defined as necessity of endotracheal intubation due to respiratory insufficiency within 48 hours in children receiving noninvasive ventilation in pediatric critical care units. Statistical analysis will be performed according to answers to form-I question-6 and form-III question-1 in the questionnaire.

  one year

• To determine the incidence of NIV failure as re-intubation within 48 hours.

  NIV failure is also determined as re-intubation within 48 hours for those who were previously intubated and received noninvasive ventilation following extubation. Second primary outcome will be evaluated by Form - I question-6 and Form - III question-1.

  1 year

Secondary Outcomes (4)

• To determine the reasons resulting in NIV failure in children enrolled in the study

  one year

• To explore complication rates directly related to noninvasive ventilation.

  one year

• To observe NIV success for those who receive noninvasive ventilation over 48 hours

  one year

• To explore prognosis of patients receiving noninvasive ventilation

  one year

Study Arms (2)

NIV Failure Group

NIV Failure Group consisted of children who failed their noninvasive ventilation session and required intubation or re-intubation

Other: noninvasive ventilation respiratory support

NIV success group

Children who successfully managed their noninvasive ventilation therapy

Other: noninvasive ventilation respiratory support

Interventions

noninvasive ventilation respiratory support OTHER

NIV Failure Group; NIV success group

Eligibility Criteria

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

Study Population

all noninvasively ventilated children from one month to eighteen years will be enrolled in this study

You may qualify if:

• noninvasively ventilated children
• age: 1 month - less than 18 years

Sponsors & Collaborators

• Akdeniz University: lead
• Ankara University: collaborator
• Cukurova University: collaborator
• Dokuz Eylul University: collaborator
• Ege University: collaborator
• Izmir Katip Celebi University: collaborator
• TC Erciyes University: collaborator
• Marmara University: collaborator
• Koç University: collaborator
• Ondokuz Mayıs University: collaborator

Study Sites (2)

Akdeniz University Faculty of Medicine Department of Pediatrics Division of Pediatric Critical Care

Antalya, 07059, Turkey (Türkiye)

Location

Akdeniz University Faculty of Medicine

Antalya, 07059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Oguz Dursun, Asc. Prof.

  Akdeniz University Faculty of Mediciane

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: March 1, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: November 1, 2018
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)