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

Primary Purpose

Respiratory Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High Flow Nasal Oxygen Therapy
Nasal CPAP
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Ethics Committee of Xinhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

High Flow Nasal Oxygen Therapy

Nasal CPAP

Arm Description

Patients are randomized to the high flow nasal oxygen therapy group

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

Outcomes

Primary Outcome Measures

the number of patients in each group who require endotracheal intubation w

Secondary Outcome Measures

mechanical ventilation-free to day 28

Full Information

First Posted
July 23, 2017
Last Updated
May 24, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03534960
Brief Title
High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
Official Title
High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2018 (Actual)
Primary Completion Date
November 12, 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Oxygen Therapy
Arm Type
Other
Arm Description
Patients are randomized to the high flow nasal oxygen therapy group
Arm Title
Nasal CPAP
Arm Type
Other
Arm Description
Patients are randomized to the nasal continuous positive airway pressure treatment group
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Oxygen Therapy
Intervention Description
Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
Intervention Type
Device
Intervention Name(s)
Nasal CPAP
Intervention Description
Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O
Primary Outcome Measure Information:
Title
the number of patients in each group who require endotracheal intubation w
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
mechanical ventilation-free to day 28
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bin he
Phone
021-25077828
Email
hebinicu@139.com
First Name & Middle Initial & Last Name or Official Title & Degree
xingyu tong
Email
2433928723@qq.com
Facility Information:
Facility Name
Ethics Committee of Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangyu Chen, PhD
Phone
+86-02125076143
Email
xinhuacru@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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