Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation

July 15, 2016 updated by: RongChang Chen, Guangzhou Institute of Respiratory Disease

Evaluation of 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: COPD patients
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®" ）
See details from arm descriptions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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.
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.
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 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.
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 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Institute of Respiratory Disease

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rongchang Chen, MD, Guangzhou Institute of Respiratory Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009CB522112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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