High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2017
CompletedStudy Start
First participant enrolled
January 13, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 29, 2018
May 1, 2018
10 months
July 23, 2017
May 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
the number of patients in each group who require endotracheal intubation w
24 hours
Secondary Outcomes (1)
mechanical ventilation-free to day 28
28 days
Study Arms (2)
High Flow Nasal Oxygen Therapy
OTHERPatients are randomized to the high flow nasal oxygen therapy group
Nasal CPAP
OTHERPatients are randomized to the nasal continuous positive airway pressure treatment group
Interventions
Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O
Eligibility Criteria
You may qualify if:
- Age ranges from 1 to 18 years
- Hypercapnic respiratory failure:
- PaO2\<60mmHg and PaCO2 \>50 mmHg
- Candidate for non-invasive respiratory support as a result of:
- an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support
- an intention to extubate the patient being managed with intubated respiratory support to non-invasive support
You may not qualify if:
- Participation in a concurrent study that prohibits the use of HHFNC
- Active air leak syndrome
- Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,
- Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia
- PaCO2\<50mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ethics Committee of Xinhua Hospital
Shanghai, Shanghai Municipality, 200092, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 23, 2017
First Posted
May 23, 2018
Study Start
January 13, 2018
Primary Completion
November 12, 2018
Study Completion
December 1, 2018
Last Updated
May 29, 2018
Record last verified: 2018-05