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

Not Applicable

• Conditions: Respiratory Insufficiency
• Interventions: Device: High Flow Nasal Oxygen Therapy; Device: Nasal CPAP

• Registration Number: NCT03534960
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

Study Timeline

• Study First Submitted: 2017-07-23
• Study Start: 2018-01-13
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-13
• Study First Posted: 2018-05-23
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-05-29
• Primary Completion: 2018-11-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Flow Nasal Oxygen Therapy	High Flow Nasal Oxygen Therapy	Patients are randomized to the high flow nasal oxygen therapy group
Nasal CPAP	Nasal CPAP	Patients are randomized to the nasal continuous positive airway pressure treatment group

Primary Outcome Measures

Name	Time	Method
the number of patients in each group who require endotracheal intubation w	24 hours

Secondary Outcome Measures

Name	Time	Method
mechanical ventilation-free to day 28	28 days

Trial Locations

Locations (1)

Ethics Committee of Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China