Respiratory Insufficiency
Conditions
Brief summary
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure.
Detailed description
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure
Interventions
Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
DEVICENasal CPAP
Standard nasal CPAP via bubble or ventilator support at levels of 4-8 cm H2O
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age ranges from 1 to 18 years 2. Hypercapnic respiratory failure: PaO2\<60mmHg and PaCO2 \>50 mmHg 3. Candidate for non-invasive respiratory support as a result of: 1. an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support 2. an intention to extubate the patient being managed with intubated respiratory support to non-invasive support
Exclusion criteria
1. Participation in a concurrent study that prohibits the use of HHFNC 2. Active air leak syndrome 3. Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis, 4. Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia 5. PaCO2\<50mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the number of patients in each group who require endotracheal intubation w | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| mechanical ventilation-free to day 28 | 28 days |
Countries
China
Contacts
Primary Contactbin he
Backup Contactxingyu tong
Outcome results
None listed