The Edi Level and Cardiopulmonary Function Between HHHFNC and Unheated Humidified High-Flow Oxygen Mask in COPD

NCT ID: NCT03811158

Last Updated: 2022-10-27

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

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2022-07-31

Brief Summary

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Patients with COPD exacerbation usually need respiratory support after extubation. Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has seminar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. There are no clinical data of diaphragm electrical activity and cardiopulmonary function for using HHHFNC and UHFOM as post-extubation respiratory support.

Detailed Description

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Objectives: The aim of this study is to compare the Edi level and cardiopulmonary parameters between heated humidified high-flow nasal cannula (HHHFNC) versus unheated high-flow oxygen mask (UHFOM) in acute exacerbation of chronic obstructive pulmonary disease (COPD) patients with post-extubation respiratory support. This is the first clinical trial to investigate and analysis the variations of cardiopulmonary parameters and Edi level between HHHFNC and UHFOM in adult patients.

Conditions

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Chronic Obstructive Lung Disease Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover. The primary outcome measure is the diaphragm electrical activity. The secondary outcome measures include the cardiopulmonary function, length of hospital stay, and re-intubation rate.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
All data will be decoded before biostatics analysis

Study Groups

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HHHFNC group

On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min

Group Type EXPERIMENTAL

HHHFNC

Intervention Type DEVICE

Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.

UHFOM group

On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min

Group Type SHAM_COMPARATOR

UHFOM

Intervention Type DEVICE

Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.

Interventions

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HHHFNC

Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.

Intervention Type DEVICE

UHFOM

Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.

Intervention Type DEVICE

Other Intervention Names

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Study group Control group

Eligibility Criteria

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Inclusion Criteria

1. AE of COPD received intubation and ready to be weaning
2. P/F ratio \> 200 during SBT before extubation

Exclusion Criteria

1. Unable to insert NG tube
2. Refuse to re-intubated when respiratory failure after extubation
3. Planned NIV use after extubation
4. Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Ke-Yun, Chao

Group leader of Respiratory Therapists

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke-Yun Chao, M.Sc

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.

Reference Type RESULT
PMID: 25558703 (View on PubMed)

Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.

Reference Type RESULT
PMID: 25980660 (View on PubMed)

Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.

Reference Type RESULT
PMID: 27771739 (View on PubMed)

Other Identifiers

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PL-201705001-M

Identifier Type: -

Identifier Source: org_study_id

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