Suspended

HIFLOWCFHigh Flow Nasal Oxygen for Children With Cystic Fibrosis Presenting With Respiratory Failure - a Randomized Controlled Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Hi-flow nasal cannula

+ Venturi mask

Device
Who is being recruted

Digestive System Diseases+7

+ Infant, Newborn, Diseases

+ Lung Diseases

From 6 to 17 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of Sao Paulo
Last updated: July 5, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Introduction: Cystic fibrosis (CF) is a genetic disease that leads to chronic lung infections and recurrent respiratory exacerbations. Supplemental oxygen is usually required during respiratory exacerbations. Recently, a new high flow nasal cannula system that provides flows up to 40l/min at 100% humidification was developed and tested in neonates and children, providing greater comfort to the patient. The main hypothesis of the study is that this method has advantages for oxygen supplementation to patients with CF hospitalized for respiratory exacerbation. Methods: 40 patients with CF aged 6 to 18 years will be randomized to receive supplemental oxygen via nasal cannula or Venturi masks during hospitalization for respiratory exacerbation. Main outcomes will be the duration of hospitalization and oxygen supplementation, viscosity and transportability of sputum and personal impressions of patients regarding the method of oxygen administration (questionnaire). Spirometry and venous blood gas analysis will be performed after the second hospital day, and sputum samples will be obtained in the first and third day of hospitalization. Clinical treatment (antibiotics, etc) will be defined by the medical team of the institution, not involved in the study. Expected Results: The use of high flow nasal cannula will result in significantly less time of supplemental oxygen, with increased comfort for patients, without significant differences in the levels of PaCO2. Sputum samples obtained from the patients treated with the high flow nasal cannula will have lower viscosity and higher transportability as compared to those obtained from patients treated with Venturi mask.

Principal SponsorUniversity of Sao Paulo
Last updated: July 5, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesInfant, Newborn, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPancreatic DiseasesRespiration DisordersRespiratory Tract DiseasesGenetic Diseases, InbornCystic FibrosisRespiratory Insufficiency

Criteria

6 inclusion criteria required to participate
Ability to perform lung function testing

Age between 6 and 17 years

Established diagnosis of cystic fibrosis

Hospital admission due to acute pulmonary exacerbation in the last 12h

Show More Criteria

5 exclusion criteria prevent from participating
Hemoptysis or pneumothorax

Need for a bronchoscopy during admission

Need for non-invasive ventilation for more than 2 hours/day

Recent admission (less than 30 days)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This group will receive supplemental oxygen by nasal cannula using the Optiflow system, with high flows of 100% humidified oxygen

Group II

Active Comparator
This group will receive supplemental oxygen by the current standard in our Institution: Venturi masks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Instituto da Criança, Hospital das Clínicas da FMUSP

São Paulo, BrazilOpen Instituto da Criança, Hospital das Clínicas da FMUSP in Google Maps
SuspendedOne Study Center