|- candidate number||19372|
|- NTR Number||NTR4764|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-aug-2014|
|- Secondary IDs||RTPO 924 Regionale Toetsingscommissie PatiŽntgebonden Onderzoek Leeuwarden|
|- Public Title||A comparison between two diagnostic tools to identify dynamic hyperinflation in COPD-patients: |
1. Metronome-Paced hyperventilation and
2. Cardio pulmonary exercise test
|- Scientific Title||A comparison between two diagnostic tools to identify dynamic hyperinflation in COPD-patients:|
1. Metronome-Paced hyperventilation with inspiratory capacity manoeuvres.
2. CPET with inspiratory capacity manoeuvres.
|- hypothesis||Dynamic hyperinflation in patients with COPD is not different in cardio pulmonary exercise testing (CPET) from dynamic hyperinflation in metronome paced hyperventilation test (MPH). |
|- Healt Condition(s) or Problem(s) studied||COPD, Dynamic hyperinflation|
|- Inclusion criteria||1. COPD with FEV1/VC< LLN. (All GOLD classes included)|
2. Age > 17 years.
3. Sent for CPET (all indications) by pulmonologist.
|- Exclusion criteria||1. Not able to perform Inspiratory Capacity manoeuvre well |
2. No informed consent
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2014|
|- planned closingdate||1-sep-2015|
|- Target number of participants||110|
|- Interventions||Addition of Metronome paced hyperventilation test prior to CPET: in both tests IC manoeuvres shall be performed as a measure for dynamic hyperinflation.|
All participants will perform both tests.
CPET (bycicle): IC manouevres: basal and at maximum exercise.
MPH: IC manoeuvres: basal and after 20 sec ventilating at double resting respiratory rate.
|- Primary outcome||Difference in IC manoeuvre (in ml) between basal and post-test value of both tests (CPET and MPH).|
|- Secondary outcome||none|
|- Timepoints||See above: interventions|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| J. Maten, van der|
|- CONTACT for SCIENTIFIC QUERIES|| J. Maten, van der|
|- Sponsor/Initiator ||Medical Center Leeuwarden |
(Source(s) of Monetary or Material Support)
|- Brief summary||Referring to paper of AJMC Laheije et al (Clin Physiol Funct Imaging 2013;33:62-69) in this observational study, we want to investigate whether in our hands (Medical Centre Leeuwarden, pulmonary function department) there is no difference between dynamic hyperinflation (assessed by change in inspiratory capacity) in patients with COPD between metronome paced hyperventilation test (MPH) and cardio pulmonary exercise testing (CPET) as gold standard test.|
|- Main changes (audit trail)|
|- RECORD||29-aug-2014 - 27-sep-2014|