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

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03534960
• Other study ID #: XH-17-007
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2018
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: bin he
• Phone: 021-25077828
• Email: hebinicu[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• High Flow Nasal Oxygen Therapy
Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
• Nasal CPAP
Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O

Locations

Country	Name	City	State
China	Ethics Committee of Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of patients in each group who require endotracheal intubation w		24 hours
Secondary	mechanical ventilation-free to day 28		28 days