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

NCT ID: NCT03534960

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-13

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Flow Nasal Oxygen Therapy

Patients are randomized to the high flow nasal oxygen therapy group

Group Type OTHER

High Flow Nasal Oxygen Therapy

Intervention Type DEVICE

Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas

Nasal CPAP

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

Group Type OTHER

Nasal CPAP

Intervention Type DEVICE

Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Nasal CPAP

Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bin He

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ethics Committee of Xinhua Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

bin he

Role: CONTACT

021-25077828

xingyu tong

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guangyu Chen, PhD

Role: primary

+86-02125076143

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XH-17-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CPAP for Infantile Pompe Disease
NCT02405624 UNKNOWN PHASE4