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

October 25, 2022 updated by: Ke-Yun, Chao, Fu Jen Catholic University

The Diaphragm Activity Level and Cardiopulmonary Function Between Heated Humidified High-Flow Nasal Cannula and Unheated Humidified High-Flow Oxygen Mask in Acute Exacerbation of COPD Patients as Post-Extubation Respiratory Support

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

2

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

  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Fu Jen Catholic University Hospital, Fu Jen Catholic University

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HHHFNC group
On HHHFNC FiO2 will setting as same as SBT before extubation Flow rate: 50L/min
Device: 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.
Other Names:
  • Study group
SHAM_COMPARATOR: UHFOM group
On Aerosol mask FiO2 will setting as same as SBT before extubation Flow rate: 15L/min
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.
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm electrical activity
Time Frame: 2 days
In voltage
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PtcO2 & PtcCO2
Time Frame: 2 days
In mmHg
2 days
Re-intubation rate
Time Frame: 2 days
In %
2 days
Cardiac index
Time Frame: 2 days
In L/min/m2
2 days
Hospital stay
Time Frame: through study completion, an average 3 months
In days
through study completion, an average 3 months
ICU stay
Time Frame: through study completion, an average 1 months
In days
through study completion, an average 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University

Investigators

  • Principal Investigator: Ke-Yun Chao, M.Sc, ck_qq@hotmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 21, 2018

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

July 31, 2022

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (ACTUAL)

January 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL-201705001-M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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