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

NCT03554460 | Completed

• 1 other identifier: GIRD201802
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• fractional concentration of inspired CO2

  FiCO2

  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 Outcomes (3)

• inspiratory flow of the inhalation limb

  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.

• expiratory flow of the exhalation limb

  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.

• breathing pattern

  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.

Study Arms (1)

dual-limb NIV

EXPERIMENTAL

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.

Device: dual-limb NIV

Interventions

dual-limb NIV DEVICE

dual-limb NIV was served with servo i ventilator

dual-limb NIV

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Rongchang Chen

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 13, 2018
• Study Start: June 23, 2018
• Primary Completion: February 3, 2019
• Study Completion: March 31, 2019
• Last Updated: July 30, 2019

Record last verified: 2018-06

Locations

CN (1)