Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation

NCT02655484 | Completed DMC

• 1 other identifier: 2009CB522112
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; noninvasive ventilation; exercise; CO2 rebreathing

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (8)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

COPD patients

OTHER

Oxygen was delivered to the face mask by a tube at a constant rate (5L/min) to keep the fingertip oxygen saturation at 90% or above. Ventilatory assistance was delivered using a BiPAP® Vision® ventilator (Respironics, Murrysville, Pennsylvania, USA) in BiPAP mode applied via a tightly fitting full face mask (Curative, Suzhou, China). A symptom-limited cycle exercise test was performed while assisted by non-invasive ventilation (NIV). All measurements were recorded at inspiratory pressure of 14 cmH2O, expiratory pressure of 4 cmH2O during rest and exercise. Breathing pattern, mean exhalation flow, mean plateau exhalation valve flow, the mean inspiratory fraction of CO2 (tidal FiCO2) reinsufflated from the circuit between the mask and the exhalation valve was measured for each breath.

Device: BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ）

Interventions

BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ） DEVICE

See details from arm descriptions.

COPD patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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;
• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Rongchang Chen, MD

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Guangzhou Institute of Respiratory Disease

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 14, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

CN (1)