Impact of Non-invasive Ventilation in Hypercapnic COPD

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University of California San Diego

Status

Terminated

Conditions

Chronic Respiratory Failure
Hypoventilation
Hypercapnia
Chronic Obstructive Pulmonary Disease
Copd

Treatments

Device: High-intensity non-invasive ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT03522805
161873

Details and patient eligibility

About

Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition worldwide and is a cause of substantial morbidity and mortality. Unfortunately, few therapies have been shown to improve survival. The importance of systemic effects and co-morbidities in COPD has garnered attention based on the observation that many patients with COPD die from causes other than respiratory failure, including a large proportion from cardiovascular causes. Recently, two high profile randomized trials have shown substantial improvements in morbidity and mortality with use of nocturnal non-invasive ventilation (NIV) in COPD patients with hypercapnia. Although the mechanisms by which NIV improves outcomes remain unclear, the important benefits of NIV might be cardiovascular via a number of mechanisms. In contrast to prior trials of NIV in COPD that did not show substantial benefit, a distinguishing feature of these encouraging recent NIV clinical trials was a prominent reduction of hypercapnia, which might be a maker or mediator of effective therapy. Alternatively, improvements might be best achieved by targeting a different physiological measure. Additional mechanistic data are therefore needed to inform future trials and achieve maximal benefit of NIV. Recent work in cardiovascular biomarkers has identified high-sensitivity troponin to have substantial ability to determine cardiovascular stress in a variety of conditions - even with only small changes. In COPD, a number of observational studies have shown that high-sensitivity troponin increases with worsening disease severity, and that levels increase overnight during sleep. This biomarker therefore presents a promising means to study causal pathways regarding the effect of NIV in patients with COPD. With this background, the investigator's overall goals are: 1) To determine whether the beneficial effect of non-invasive ventilation might be due to a reduction in cardiovascular stress, using established cardiovascular biomarkers, and 2) To define whether a reduction in PaCO2 (or alternative mechanism) is associated with such an effect.

Enrollment

6 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects with previously diagnosed severe COPD (FEV1 <50% predicted) and daytime hypercapnia (PaCO2 or TcCO2 > 45 mmHg)

Exclusion criteria

  • Lung disease besides COPD (e.g., pulmonary fibrosis, bronchiectasis, pulmonary arterial hypertension) other than well controlled asthma
  • Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
  • Uncontrolled hypertension (SBP >160, DBP >95)
  • Unwilling or unable to withhold CPAP during polysomnography
  • Presence of tracheostomy
  • Hospitalization within the past 90 days
  • Prior peptic ulcer disease, esophageal varicies, or gastrointestinal bleeding (< 5 years)
  • Prior gastric bypass surgery
  • Anticoagulant use (other than aspirin) or bleeding diathesis (only for esophageal catheter placement)
  • Chronic liver disease or end-stage kidney disease
  • Allergy to any of the study medications
  • Regular use of medications known to affect control of breathing (opioids, benzodiazepines, theophylline)
  • Insomnia or circadian rhythm disorder
  • Active illicit substance use or >3 oz nightly alcohol use
  • Psychiatric disease, other than controlled depression
  • Pregnancy
  • Prisoners
  • Cognitive impairment, unable to provide consent, or unable to carry out research procedures

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Non-invasive ventilation
Experimental group
Description:
Subjects will undergo a baseline night with standard polysomnography, followed by a treatment night using non-invasive ventilation under polysomnography
Treatment:
Device: High-intensity non-invasive ventilation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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