The Application and Analysis of HHHFNC in Walking Test of Pulmonary Rehabilitation

NCT03863821 | Completed

• 1 other identifier: PL-201808008-M
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.

Conditions

COPD; Pulmonary Disease; Rehabilitation

Keywords

chronic obstructive pulmonary disease; heated humidified high-flow nasal cannula; pulmonary rehabilitation; six-minute walking test

Outcome Measures

Primary Outcomes (1)

• Walking distance

  Meter

  6 minutes

Secondary Outcomes (5)

• Heart rate

  1 hour

• Oxygen saturation (SpO2)

  1 hour

• Transcutaneous carbon dioxide (PtcCO2)

  1 hour

• Cardiac output by non-invasive cardiometry

  1 hour

• Borg dyspnea scale

  1 hour

Study Arms (2)

HHHFNC group

EXPERIMENTAL

Practice 6 MWT with HHHFNC

Device: HHHFNC

non-HHHFNC group

NO INTERVENTION

Practice 6 MWT without HHHFNC

Interventions

HHHFNC DEVICE

HHHFNC setting: 1. Flow rate: 40L/min 2. FiO2: 0.4 HHHFNC will use immediately before 6MWT and remove at the end of 6MWT

HHHFNC group

Eligibility Criteria

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

You may qualify if:

• COPD with performed pulmonary function test

You may not qualify if:

• Left-side heart failure
• COPD exacerbation within 3 month
• Diagnosed neuromuscular disease
• Unable to perform 6-MWT

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 (4)

• Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.

  PMID: 27578482 RESULT

• Maltais F, Singh S, Donald AC, Crater G, Church A, Goh AH, Riley JH. Effects of a combination of umeclidinium/vilanterol on exercise endurance in patients with chronic obstructive pulmonary disease: two randomized, double-blind clinical trials. Ther Adv Respir Dis. 2014 Dec;8(6):169-81. doi: 10.1177/1753465814559209.

  PMID: 25452426 RESULT

• Man WD, Mustfa N, Nikoletou D, Kaul S, Hart N, Rafferty GF, Donaldson N, Polkey MI, Moxham J. Effect of salmeterol on respiratory muscle activity during exercise in poorly reversible COPD. Thorax. 2004 Jun;59(6):471-6. doi: 10.1136/thx.2003.019620.

  PMID: 15170026 RESULT

• Chao KY, Liu WL, Nassef Y, Tseng CW, Wang JS. Effects of high-flow nasal cannula with oxygen on self-paced exercise performance in COPD: A randomized cross-over trial. Medicine (Baltimore). 2021 Dec 23;100(51):e28032. doi: 10.1097/MD.0000000000028032.

  PMID: 34941043 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group leader of Respiratory Therapists

Model Details: Participants with COPD who done pulmonary function test will enroll to this study. Left-side heart failure, COPD AE within 3 months, diagnosed neuromuscular disease, and unable to perform 6-MWT will be exclude. Participants will received HHHNFC or non-HHHFNC support during the 6-MWT.

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 5, 2019
• Study Start: March 18, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)