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Completed

NCT Number: NCT02611947

CT Indexes of Emphysema and Airways in Healthy Volunteers: Normal Values; Relations With Gender, Height and Weight

Various indexes have been proposed to quantify both pulmonary emphysema and airways disease on chest CT scans. It is unknown whether these indexes should be consider in absolute values or as compared to predicted normal values. The purposes of the present study is thus : a) to measure these indexes at CT in healthy volunteers; b) to investigate their relations with gender, height and weight.

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Key information

Conditions

Healthy Airway Remodeling Emphysema Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme University Hospital

Brussels, Brussels Capital, 1070, Belgium

About this study

87 healthy volunteers performed consecutively a low-dose chest CT scan and pulmonary function tests:

  • On chest CT scans, indexes reflecting pulmonary emphysema and airways measurements have been computed by using dedicated softwares. Each of our three readers performed two reading sessions.

Relative area of lung parenchyma with attenuation value less than -960 Hounsfield Units; luminal area and wall thickness in third and fourth generations airways were recorded.

  • Pulmonary function tests were performed: vital capacity, forced vital capacity , functional residual capacity, total lung capacity, residual volume, forced expiratory volume in one second, and diffusion lung capacity for carbon monoxide were recorded (either in absolute values and percentage of predicted values).

CT indexes were compared with gender, height and weight.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Never smoked.
  • No respiratory infection in the 4 weeks before the begin of the study.
  • No history of pulmonary resection.
  • No active malignancy or malignancy of any organ system within the past 5 years.

Exclusion criteria

  • no exclusion criteria

Treatment and study plan

Low-dose chest CT scans

Radiation

Supine chest CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length)

35 quality ref mAs with care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm

Primary outcomes

  1. CT index - RA960 (%)

    Time frame: 4 hours

    From acquired data, images were reconstructed using a soft algorithm. On these soft images, the relative area of lung parenchyma with attenuation value less than -960 Hounsfield Units was computed (expressed in %), as an index representative of pulmonary emphysema extent.

  2. CT index - LA3rd (mm2)

    Time frame: 4 hours

    From acquired data, images were reconstructed using a high resolution algorithm. On these high-resolution images, the airway lumen was measured in third generations of airways (expressed in mm2).

  3. CT index - LA4th (mm2)

    Time frame: 4 hours

    From acquired data, images were reconstructed using a high resolution algorithm. On these high-resolution images, the airway lumen was measured in fourth generations of airways (expressed in mm2).

  4. CT index - WT3rd (mm)

    Time frame: 4 hours

    From acquired data, images were reconstructed using a high resolution algorithm. On these high-resolution images, the airway wall was measured in third generations of airways (expressed in mm).

  5. CT index - WT4th (mm)

    Time frame: 4 hours

    From acquired data, images were reconstructed using a high resolution algorithm. On these high-resolution images, the airway wall was measured in fourth generations of airways (expressed in mm).

Secondary outcomes

  1. Pulmonary function tests - VC (l)

    Time frame: 4 hours

    Vital capacity was measured (expressed in l).

  2. Pulmonary function tests - FVC (l)

    Time frame: 4 hours

    Forced vital capacity was measured (expressed in l).

  3. Pulmonary function tests - FRC (l)

    Time frame: 4 hours

    Functional residual capacity capacity was measured (expressed in l).

  4. Pulmonary function tests - TLC (l)

    Time frame: 4 hours

    Total lung capacity was measured (expressed in l).

  5. Pulmonary function tests - RV (l)

    Time frame: 4 hours

    Residual volume was measured (expressed in l).

  6. Pulmonary function tests - FEV1 (l)

    Time frame: 4 hours

    Forced expiratory volume in one second was measured (expressed in l).

  7. Pulmonary function tests - DLCO (ml/min/ mmHg)

    Time frame: 4 hours

    Diffusion lung capacity for carbon monoxide was measured (expressed in ml/min/ mmHg)

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2015
Registry last updated
Nov 23, 2015

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

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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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