High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage

Shanghai Jiao Tong University

Status: Unknown

Conditions: Respiratory Insufficiency

Treatments: Device: Nasal CPAP; Device: High Flow Nasal Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03534960

XH-17-007

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

High Flow Nasal Oxygen Therapy

Other group

Description:

Patients are randomized to the high flow nasal oxygen therapy group

Treatment:

Device: High Flow Nasal Oxygen Therapy

Nasal CPAP

Other group

Description:

Patients are randomized to the nasal continuous positive airway pressure treatment group

Treatment:

Device: Nasal CPAP