The Physiological Effect of High Flow Oxygen Therapy

NCT ID: NCT04212182

Last Updated: 2019-12-30

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-27

Study Completion Date

2020-07-01

Brief Summary

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Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.

Detailed Description

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Conditions

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High-flow Nasal Cannula Non-invasive Positive Pressure Ventilation Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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HFNC group

AECOPD patients receive ventilation support via HFNC.

Group Type EXPERIMENTAL

HFNC

Intervention Type DEVICE

HFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs.

NPPV group

AECOPD patients receive ventilation support via NPPV.

Group Type ACTIVE_COMPARATOR

NPPV

Intervention Type DEVICE

NPPV is the standard therapy for ventilatory failure in AECOPD.

Interventions

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HFNC

HFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs.

Intervention Type DEVICE

NPPV

NPPV is the standard therapy for ventilatory failure in AECOPD.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* AECOPD patients with acute hypercapnic respiratory failure

Exclusion Criteria

* other lung/pleural diseases or thoracic deformity
* severe heart failure (New York Heart Association class IV), severe dysrhythmia
* unstable angina, or malignant comorbidity
* obesity (BMI ≥ 35 kg/m²)
* severe obstructive sleep apnea syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Rongchang Chen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rongchang Chen, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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The First Affiliated Hospital of Guangzhou Medical University.

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lili Guan, PhD

Role: CONTACT

Phone: +8613422288665

Email: [email protected]

Facility Contacts

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Lili Guan, PhD

Role: primary

Other Identifiers

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GIRH-HFNC8306

Identifier Type: -

Identifier Source: org_study_id