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Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation

Primary Purpose

Asthma Acute

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High Flow Nasal cannula
NIV Noninvasive Ventilation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma Acute focused on measuring asthma, High flow nasal cannula, Non invasive ventilation

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 5 and 16 years;
  • both genders;
  • Be in the presence of the bronchospasm crisis;
  • Be admitted to HICF Hospital;
  • Have signed the search terms

Exclusion Criteria:

  • Having associated heart disease;
  • neurological/cognitive impairment;
  • Have severe respiratory insufficiency detected by severity scores;
  • Intolerance to any type of treatment

Sites / Locations

  • Nove de Julho University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High Flow nasal cannula

NIV noninvasive ventilation

Arm Description

It will be administered as part of the high-flow nasal cannula treatment to reduce the symptoms of acute asthma

It will be administered as part of the Noninvasive ventilation treatment to reduce the symptoms of acute asthma

Outcomes

Primary Outcome Measures

PAS Pediatric Asthma Score
PAS Pediatric Asthma Score- This score assesses respiratory distress and wheezing. Higher score the more severe the asthma attack. The score ranges from 3 to 15 and clinical improvement is expected when there is a reduction of 3 points or more.
Suplemental Oxigen day use
Oxigen dose number of days used

Secondary Outcome Measures

Forced Expiratory volume in first second
FEV1 liters and percentage
Bronchodilator doses ( Salbutamol)
Amount of puffs administered per day

Full Information

First Posted
July 12, 2019
Last Updated
July 23, 2019
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT04033666
Brief Title
Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation
Official Title
Comparative Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation in Acute Asthmatic Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study compares two types of noninvasive treatments for asthma attacks with the objective of analyzing the efficacy of each therapy during the period of exacerbations in infants and asthmatics hospitalized.
Detailed Description
A randomized clinical trial, where it will be established, treatment in hospitalized asthma patients in the infirmary and Emergency Room of the Hospital Infantil Cândido Fontoura. The children eligible for the Protocol, after signing the terms of consent and assent, will be randomized for treatment in 2 groups (GI - bilevel and GII - High Flow Nasal Cannula). After the evaluations are started: Feb1, Volume expired in the first second; Peak Flow, vital signs and calculated Pulmonary Asthma Score, Pulmonary Asthma Severity Score, Pulmonary Index Score, and therapy application. The N to be considered for the study of 20 individuals per group. Group therapy I will be applied in diaphragmatic re-education exercises 3 x 10 breaths, after non-invasive ventilation, with parameters 12 cm H2O Ipap and Epap 8 cm H2O, for 45 minutes, according to patient tolerance, interface, with full face mask After treatment, reassessment of vital signs and measurements of Peak Flow, Fev1 and Severity Scores. The GII will be established therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight and respiratory rate at the time of evaluation, ranging from 2 l / min to 30 l / min. flow. The therapy will begin with diaphragmatic exercises 3 x 10 breaths, after 45 minutes of the installation of the therapy that is continuous, will be performed a reassessment of vital signs and Peak Flow, Feb, Severity Scores. During the hospitalization time of the child will be carried out the daily treatment, therapy chosen for each patient for 45 minutes in the case of GI and the GII group daily follow-up and adjustment of flow dosage, also evaluated the vital signs, vital signs and Peak Flow, Feb, Gravity Scores. At the time of hospital discharge, the evaluations will be performed and data such as inhaled corticosteroid use, oxygen use in days and inspired fraction, hospitalization days, hospital costs, as well as vital signs, vital signs and Peak Flow, Fev, Scores of Gravity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Acute
Keywords
asthma, High flow nasal cannula, Non invasive ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized clinical trial comparing high-flow nasal cannula intervention with non-invasive ventilation with two levels of pressure in children hospitalized for acute asthma
Masking
InvestigatorOutcomes Assessor
Masking Description
The outcome accessor and the investigator when evaluating the child and the spreadsheet data will not know which therapy the patient was submitted to.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Flow nasal cannula
Arm Type
Active Comparator
Arm Description
It will be administered as part of the high-flow nasal cannula treatment to reduce the symptoms of acute asthma
Arm Title
NIV noninvasive ventilation
Arm Type
Active Comparator
Arm Description
It will be administered as part of the Noninvasive ventilation treatment to reduce the symptoms of acute asthma
Intervention Type
Other
Intervention Name(s)
High Flow Nasal cannula
Other Intervention Name(s)
HFNC
Intervention Description
The HFNC will be instituted therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight, ranging from 2 l / min to 30 l / min. The therapy will begin with diaphragmatic exercises 3x10 breaths and after high-flow therapy with nasal cannula for 45 minutes, after which will be performed the vital signs evaluations and Peak Flow, HRV, FEV1.
Intervention Type
Other
Intervention Name(s)
NIV Noninvasive Ventilation
Other Intervention Name(s)
NIV
Intervention Description
The Therapy consisted of 3x10 diaphragmatic re-education exercises after a Bipap device was coupled in bipedal mode with parameters Ipap 12 cm H2O and Epap 8 cm H2O, for 45 minutes, according to the patient's tolerance, with Full face facial mask. After therapy evaluated vital signs and measures of Peak Flow, HRV, FEV1.
Primary Outcome Measure Information:
Title
PAS Pediatric Asthma Score
Description
PAS Pediatric Asthma Score- This score assesses respiratory distress and wheezing. Higher score the more severe the asthma attack. The score ranges from 3 to 15 and clinical improvement is expected when there is a reduction of 3 points or more.
Time Frame
Change from baseline PAS at first 45 minutes and 5th day in hospital
Title
Suplemental Oxigen day use
Description
Oxigen dose number of days used
Time Frame
Change from baseline Oxygen dose at first 45 minutes and 5th day in hospital.
Secondary Outcome Measure Information:
Title
Forced Expiratory volume in first second
Description
FEV1 liters and percentage
Time Frame
Change from baseline FEV1 at first 45 minutes and 5th day in hospital.
Title
Bronchodilator doses ( Salbutamol)
Description
Amount of puffs administered per day
Time Frame
Change from baseline Salbutamol dose (First day and 5th day in hospital)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 5 and 16 years; both genders; Be in the presence of the bronchospasm crisis; Be admitted to HICF Hospital; Have signed the search terms Exclusion Criteria: Having associated heart disease; neurological/cognitive impairment; Have severe respiratory insufficiency detected by severity scores; Intolerance to any type of treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirceu Costa
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nove de Julho University
City
São Paulo
ZIP/Postal Code
01.504-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation

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