- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03534960
High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
May 24, 2018 updated by: Bin He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: bin he
- Phone Number: 021-25077828
- Email: hebinicu@139.com
Study Contact Backup
- Name: xingyu tong
- Email: 2433928723@qq.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200092
- Recruiting
- Ethics Committee of Xinhua Hospital
-
Contact:
- Guangyu Chen, PhD
- Phone Number: +86-02125076143
- Email: xinhuacru@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: High Flow Nasal Oxygen Therapy
Patients are randomized to the high flow nasal oxygen therapy group
|
Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
|
Other: Nasal CPAP
Patients are randomized to the nasal continuous positive airway pressure treatment group
|
Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the number of patients in each group who require endotracheal intubation w
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mechanical ventilation-free to day 28
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2018
Primary Completion (Anticipated)
November 12, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
July 23, 2017
First Submitted That Met QC Criteria
May 13, 2018
First Posted (Actual)
May 23, 2018
Study Record Updates
Last Update Posted (Actual)
May 29, 2018
Last Update Submitted That Met QC Criteria
May 24, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-17-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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