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CompletedNCT00528944Updated Jul 7, 2015

Single-Breath Measurement Underestimates Ventilatory Volume According to Emphysema Severity

An observational study in Emphysema, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years to 81 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-07.

Sponsored by Columbia University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
73
Ages
18 Years to 81 Years
Sex
All
01

Study summary

Although single breath helium (He) dilution measurement (VASB) is currently used in pulmonary function laboratories to assess functional alveolar volume and diffusing capacity for carbon monoxide, the extent to which VASB reflects ventilatory and thoracic volume has not been prospectively determined in emphysema. We hypothesized that VASB underestimates rebreathe helium dilution volume (VARB), and plethysmographic volume (VApleth) as clinical and physiologic severity of emphysema increases.

Read the detailed description

VASB, VARB, and VApleth were measured in 52 consecutive stable outpatients with clinical and radiographic emphysema. Thirteen patients with an obstructive ventilatory defect without emphysema (OVD) and 18 normal controls were similarly studied. All subjects underwent spirometry followed by whole body plethysmography and He dilution volume measurements; VASB and VARB order was randomized.

02

Conditions studied

  • Emphysema

Keywords

  • alveolar volume
  • pulmonary function testing
  • emphysema
03

In context

Pulmonary Emphysema

187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.

This study's enrollment of 73 is close to the median of 74 across 48 observational studies indexed under Pulmonary Emphysema.

Browse Pulmonary Emphysema studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 81 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This is a prospective trial in all outpatients with emphysema referred for full pulmonary function testing to the pulmonary diagnostic unit.

Inclusion criteria

  • All outpatients between the ages of 18 and 81 years referred to the Columbia University Medical Center Pulmonary Diagnostic Unit between 1/18/06 and 7/30/07 for full pulmonary function evaluation, and with an obstructive ventilatory defect on spirometry, were considered eligible.

Exclusion criteria

Exclusion Criteria:

  • Patients who did not want to undergo the re-breathe diffusing capacity testing
  • Patients who could not give informed consent;and
  • Patients who were too physically compromised to undergo full testing including the re-breathe maneuver as deemed by our technicians.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
73 participants (actual)

Groups and cohorts

  • Cohort A

    Patients with obstructive defects and radiological evidence of emphysema

  • Cohort B

    Patients with obstructive ventilatory defects and no radiological evidence of emphysema

  • Cohort C

    Non-smokers without obstructive ventilatory defects or history of cardiopulmonary disease

06

What researchers measure

Primary outcomes

  1. Difference between DLCO SB alveolar volume and the total lung volume measurement from plethysmography

    To test the hypothesis that DLCO SB underestimates DLCO derived by the re-breathe DLCO maneuver, and that VA SB similarly underestimates VA RB. Alveolar volume derived with the two maneuvers will be compared with body plethysmography, the gold standard of total lung volume measurement in patients with emphysema.

    Time frame: 10 seconds

  2. Difference between DLCO RB alveolar volume and the total lung volume measurement from plethysmography

    To test the hypothesis that DLCO SB underestimates DLCO derived by the re-breathe DLCO maneuver, and that VA SB similarly underestimates VA RB. Alveolar volume derived with the two maneuvers will be compared with body plethysmography, the gold standard of total lung volume measurement in patients with emphysema.

    Time frame: 10 seconds

07

Study locations

1 site
  • Columbia University Cardiopulmonary, Sleep and Ventilatory Disorders Center
    NY, New York 10032, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00528944
Lead sponsor
Columbia University
Responsible party
Sponsor
First posted
Sep 14, 2007
Start date
Jan 2006
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Jul 7, 2015

Study contacts

Robert C Basner, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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