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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Ethics Committee of Xinhua Hospital
        • Contact:

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:

  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 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
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
Other: Nasal CPAP
Patients are randomized to the nasal continuous positive airway pressure treatment group
Device: Nasal CPAP
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.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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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