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Completed

NCT Number: NCT02655484

Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

See details from arm descriptions.

Primary outcomes

  1. mean exhalation valve flow

    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 outcomes

  1. mean exhalation flow

    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.

  2. mean inspiratory fraction of CO2 for each tidal volume

    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.

  3. fraction of end-tidal carbon dioxide partial pressure

    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.

  4. inspiratory time

    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.

  5. expiratory time

    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.

  6. respiratory rate

    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.

  7. inspiratory tidal volume

    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.

  8. expiratory tidal volume

    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.

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 14, 2016
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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