Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Evaluation of Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655484
• Other study ID #: 2009CB522112
• Status: Completed
• Phase: N/A
• First received: January 6, 2016
• Last updated: July 15, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects or patients with COPD ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for predicting CO2 rebreathing.

Description:

Non-invasive ventilation circuit consists of single-limb tubing for inspiration and expiration, including a plateau exhalation valve. As exhaled gases was vented out the plateau exhalation valve at a constant rate, during exercise, with the increase of exhalation flow, single-limb circuit with a plateau exhalation valve might cause carbon dioxide(CO2) rebreathing. Therefore, our aim in the present study was to evaluate whether CO2 rebreathing occurs in COPD patients ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve and estimate a potential threshold for predicting CO2 rebreathing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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;

• oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen (FiO2) = 0.5;

• patients with musculoskeletal or neurological disorders;

• or failure to comply with the research protocol.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• BiPAP® Vision® ventilator("Ventilator", "Philips Respironics™ BiPAP® Vision®" )
See details from arm descriptions.

Locations

Country	Name	City	State
China	State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean exhalation valve flow		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.	No
Secondary	mean exhalation flow		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.	No
Secondary	mean inspiratory fraction of CO2 for each tidal volume		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.	No
Secondary	fraction of end-tidal carbon dioxide partial pressure		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.	No
Secondary	inspiratory time		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.	No
Secondary	expiratory time		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.	No
Secondary	respiratory rate		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.	No
Secondary	inspiratory tidal volume		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.	No
Secondary	expiratory tidal volume		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.	No