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Completed

NCT Number: NCT02012101

Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD

The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients.

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Key information

Age range

30 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 College

Guangzhou, Guangdong, 510120, China

About this study

Chronic obstructive pulmonary disease(COPD) is a preventable and treatable illness, which is clinically characterized by persistent airflow limitation that is usually progressive. It's well known that airflow limitation lead to air trapping particularly during exercise, resulting in increased dyspnea and limitation of exercise capacity. Thus, COPD patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea. The sedentarism results in physical deconditioning and alterations of the peripheral muscles, and the latter one causes more exertional dyspnea and fatigue, which in turn leads to much more sedentarism, forming the vicious cycle of sedentarism, dyspnea/fatigue and more sedentarism. Thereby, measures should be taken to interrupt this vicious cycle. Some previous studies suggested that niv acting as an add-on therapy could help unloading the inspiratory muscle, reducing the dynamic compression of the airway, diminishing the dynamic hyperinflation,to some extent, relieved dyspnea during exercise in COPD patients. However,those measures were taken during exercise, acting as an add-on therapy. Whether NIV can play a role as a rescue therapy to relieve exertional dyspnea while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication is still not quite clear. Therefore, we hypothesize that niv as a rescue-therapy has the same effect on relieving dyspnea in stable severe COPD patients just like the add-on therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • severe COPD (post bronchodilator FEV1/FVC < 70% and FEV1 < 50% predicted)
  • stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
  • dyspnea as a main symptom that limited daily activities

Exclusion criteria

  • obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination
  • facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
  • oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen(FiO2) ≥ 0.5
  • systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg at rest
  • unstable angina or a myocardial infarct in the previous four weeks
  • resting sinus tachycardia ( > 120 beats/min)
  • patients with musculoskeletal or neurological disorders
  • patients who are unable to give informed consent

Treatment and study plan

niv plus oxygen therapy

Device

NIV given on Philips Respironics BiPAP Vision apparatus.

Other names: Philips Respironics BiPAP Vision

Oxygen therapy

Device

Primary outcomes

  1. Borg scale

    Time frame: baseline,repeated measurement for about ten minutes after intervention

Secondary outcomes

  1. Inspiratory capacity(IC)

    Time frame: baseline,repeated measurement for about ten minutes after intervention

  2. surface electromyography(sEMG)

    Time frame: baseline,repeated measurement for about ten minutes after intervention

  3. respiratory parameters

    Time frame: baseline,repeated measurement for about ten minutes after intervention

    minute ventilation(VE); tidal volume(Vt); respiratory rate(RR); inspiratory time(Ti); total duty cycle(Ttot)

  4. oxygen saturation(SpO2)

    Time frame: baseline,repeated measurement for about ten minutes after intervention

  5. Heart Rate(HR)

    Time frame: baseline,repeated measurement for about ten minutes after intervention

  6. the total recovery time

    Time frame: repeated measurement for about ten minutes after intervention

  7. mouth pressure(Pmo)

    Time frame: baseline,repeated measurement for about ten minutes after intervention

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

The Efficacy of Non-invasive Mechanical Ventilation as a Rescue Therapy for Relieving Dyspnea in Patients With Stable Severe COPD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 16, 2013
Registry last updated
Jun 24, 2014

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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