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Evaluation of CO2 Rebreathing During Exercise With the Increasing Ventilation Assisted by NIV With a Dual-limb Circuit

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dual-limb NIV
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presented clinically stable (no exacerbation in the 4 weeks prior to study
  • participation or with no change in medications);
  • physician diagnosed COPD, forced expiratory volume in 1s (FEV1) < 50% predicted; dyspnea as a main symptom that limited daily activities.

Exclusion Criteria:

  • subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray; examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy;
  • a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations;
  • a history of uncontrolled hypertension, or other respiratory diseases;
  • patients with musculoskeletal or neurological disorders;
  • failure to comply with the research protocol.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dual-limb NIV

Arm Description

A maximal cycle exercise test with the participants assisted by BiPAP (Servo i, Maquet, Siemens) receiving 10 cmH2O pressure support in addition to oxygen therapy. During the test, breathing pattern, inspiratory flow of the inhalation limb and expiratory flow of the exhalation limb, fractional concentration of inspired CO2 (FiCO2) of the inspiratory line was measured for each breath were recorded.

Outcomes

Primary Outcome Measures

fractional concentration of inspired CO2
FiCO2

Secondary Outcome Measures

inspiratory flow of the inhalation limb
Vti/Ti
expiratory flow of the exhalation limb
Vte/Te
breathing pattern
Ti、Te、Ti/Ttot、RR

Full Information

First Posted
May 30, 2018
Last Updated
July 29, 2019
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT03554460
Brief Title
Evaluation of CO2 Rebreathing During Exercise With the Increasing Ventilation Assisted by NIV With a Dual-limb Circuit
Official Title
Evaluation of Carbon-dioxide Rebreathing During Exercise With the Increasing Ventilation Assisted by Noninvasive Ventilation With a Dual-limb Circuit
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 23, 2018 (Actual)
Primary Completion Date
February 3, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Ventilated by a single-limb tubing with PEV caused CO2 rebreathing to COPD patients during exercise with the increasing ventilation. The aim of this study was to evaluate whether CO2 rebreathing could be avoided with the use of the dual-limb circuit, to provide a theoretical basis of more rational clinical application of NIV in the setting of increasing ventilation(eg, after exercise).
Detailed Description
Exercise training is a key component of pulmonary rehabilitation. It has shown signifcant improvements in both exercise tolerance and quality of life in patients with COPD. The intensity of exercise training is of great importance to yield a true physiologic effect. However, in patients with severe COPD, exertional dyspnea and leg fatigue make it impossible for the patient to maintain intensity of training for enough time to achieve a physiologic training effect. NIV has been reported to be used as support for exercise to improve exercise tolerance and respiratory performances in patients with mild-to-severe COPD with inconsistent results. Evidence from previous studies have suggested that NIV with a single-limb circuit with Whisper Swivel II expiratory valve or Plateau exhalation valve assisted during exercise in patients with COPD caused CO2 rebreathing. CO2 rebreathing may have a negative impact on efficacy. Previous studies have proved that exercise tolerance was improved ventilated by NIV with a dual-limb circuit. In theory, NIV with a dual-limb circuit consists of one inhalation limb that introduces air into the patient's airways and one exhalation limb that leads exhaled gas outside of the airways, there is no risk of rebreathing. However, there was no report on whether there's no risk of rebreathing in COPD patients ventilated during exercise by a dual-limb circuit. Therefore, the aim of the study was to determine whether there was no CO2 rebreathing occurred assisted with NIV with dual-limb circuit in patients with stable severe COPD after exercise with exertional dyspnea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dual-limb NIV
Arm Type
Experimental
Arm Description
A maximal cycle exercise test with the participants assisted by BiPAP (Servo i, Maquet, Siemens) receiving 10 cmH2O pressure support in addition to oxygen therapy. During the test, breathing pattern, inspiratory flow of the inhalation limb and expiratory flow of the exhalation limb, fractional concentration of inspired CO2 (FiCO2) of the inspiratory line was measured for each breath were recorded.
Intervention Type
Device
Intervention Name(s)
dual-limb NIV
Intervention Description
dual-limb NIV was served with servo i ventilator
Primary Outcome Measure Information:
Title
fractional concentration of inspired CO2
Description
FiCO2
Time Frame
Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
Secondary Outcome Measure Information:
Title
inspiratory flow of the inhalation limb
Description
Vti/Ti
Time Frame
Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
Title
expiratory flow of the exhalation limb
Description
Vte/Te
Time Frame
Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
Title
breathing pattern
Description
Ti、Te、Ti/Ttot、RR
Time Frame
Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presented clinically stable (no exacerbation in the 4 weeks prior to study participation or with no change in medications); physician diagnosed COPD, forced expiratory volume in 1s (FEV1) < 50% predicted; dyspnea as a main symptom that limited daily activities. Exclusion Criteria: subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray; examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy; a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations; a history of uncontrolled hypertension, or other respiratory diseases; patients with musculoskeletal or neurological disorders; failure to comply with the research protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

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Evaluation of CO2 Rebreathing During Exercise With the Increasing Ventilation Assisted by NIV With a Dual-limb Circuit

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