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

NCT03811158 | Terminated

• 1 other identifier: PL-201705001-M
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Lung Disease; Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• Diaphragm electrical activity

  In voltage

  2 days

Secondary Outcomes (5)

• PtcO2 & PtcCO2

  2 days

• Re-intubation rate

  2 days

• Cardiac index

  2 days

• Hospital stay

  through study completion, an average 3 months

• ICU stay

  through study completion, an average 1 months

Study Arms (2)

HHHFNC group

EXPERIMENTAL

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

Device: HHHFNC

UHFOM group

SHAM COMPARATOR

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

Device: UHFOM

Interventions

HHHFNC 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.

Also known as: Study group

HHHFNC group

UHFOM 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.

Also known as: Control group

UHFOM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to insert NG tube
• Refuse to re-intubated when respiratory failure after extubation
• Planned NIV use after extubation
• Pregnancy

Sponsors & Collaborators

• Fu Jen Catholic University: lead

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 25558703 RESULT

• 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.

  PMID: 25980660 RESULT

• 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.

  PMID: 27771739 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ke-Yun Chao, M.Sc

  ck_qq@hotmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All data will be decoded before biostatics analysis
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group leader of Respiratory Therapists

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 22, 2019
• Study Start: May 21, 2018
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)