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

NCT04033666 | Unknown DMC

• 1 other identifier: High Flow Nasal Cannula
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Acute

Keywords

asthma; High flow nasal cannula; Non invasive ventilation

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline PAS at first 45 minutes and 5th day in hospital

• Suplemental Oxigen day use

  Oxigen dose number of days used

  Change from baseline Oxygen dose at first 45 minutes and 5th day in hospital.

Secondary Outcomes (2)

• Forced Expiratory volume in first second

  Change from baseline FEV1 at first 45 minutes and 5th day in hospital.

• Bronchodilator doses ( Salbutamol)

  Change from baseline Salbutamol dose (First day and 5th day in hospital)

Study Arms (2)

High Flow nasal cannula

ACTIVE COMPARATOR

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

Other: High Flow Nasal cannula

NIV noninvasive ventilation

ACTIVE COMPARATOR

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

Other: NIV Noninvasive Ventilation

Interventions

High Flow Nasal cannula OTHER

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.

Also known as: HFNC

High Flow nasal cannula

NIV Noninvasive Ventilation OTHER

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.

Also known as: NIV

NIV noninvasive ventilation

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 01.504-001, Brazil

Location

Related Publications (1)

• David MMC, Gomes ELFD, Cavassini CLF, Luiz JG, Costa D. Comparison of the effects of high-flow nasal cannula and bilevel positive airway pressure treatments as respiratory physiotherapy interventions for children with asthma exacerbation: a randomized clinical trial. Einstein (Sao Paulo). 2024 Aug 26;22:eAO0588. doi: 10.31744/einstein_journal/2024AO0588. eCollection 2024.

  PMID: 39194097 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dirceu Costa

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcome accessor and the investigator when evaluating the child and the spreadsheet data will not know which therapy the patient was submitted to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 26, 2019
• Study Start: January 10, 2019
• Primary Completion: July 30, 2019
• Study Completion: November 30, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)