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MUCOCAP
The Study of Capnography for the Follow-up of Cystic Fibrosis Children With or Without Gas Trapping
Sponsor study identifier
observational
76
1 country
2
Study Start
May 5, 2021
Actual (reported)Primary Completion
October 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The respiratory system involvement in cystic fibrosis(CF) influences the prognosis and course of disease. Respiratory assessment is based on spirometry, but its main parameter, the maximal expiratory volume in the first second (FEV1), does not reflect the initial peripheral impairment of airways. Another pulmonary function test (PFT) validated for CF children follow-up is measurement of "gas trapping", reflecting ventilation inhomogeneity and incipient airways impairment. "Gas trapping" can be obtained by lung volume measurement (functional residual capacity, FRC) by plethysmography and helium dilution technique, but these tests are inconvenient for children due to their long length (\~30min). A complete PFT is routinely performed once a year. It also includes a measurement of Lung Clearance Index (LCI) reflecting ventilation inhomogeneity. Capnography is a non-invasive PFT technique, does not require subject's active cooperation, is of short duration and could replace the traditional PFT for CF children follow-up. The capnograph is integrated into the device measuring LCI and data can be retrieved and analyzed afterwards. Capnographic indices reflect ventilation inhomogeneity. The hypothesis is that capnographic indices change in the presence/absence of "gas trapping" in CF children. The main objective is to show that the capnographic index of efficacy (EFFi) is significantly different between CF children "with gas trapping" and CF children "without gas trapping". The secondary objectives are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 18, 2021
Actual (reported)March 24, 2021
Actual (reported)May 5, 2021
Actual (reported)October 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Efficiency index (EFFi) Gold standard (CRFpleth - CRFHe) / CRFpleth to differentiate between subjects "with" gas trapping (defined by> 10%) and subjects "without" gas trapping (defined by ≤10%).
Value of the capnographic efficiency index (EFFi), for each of the children of the two groups studied . easurement included in the device that measures LCI, collected after LCI measurement
through study completion, an average of 6 months
Other capnographic indices
through study completion, an average of 6 months
Forced expiratory volume in the first second (FEV1)
through study completion, an average of 6 months
Lung Clearance Index (LCI)
through study completion, an average of 6 months
CF children "with gas trapping" will be defined by a ratio between the difference of functional residual capacity (FRC) obtained by plethysmography (FRCpleth) and FRC obtained by helium dilution method (FRCHe) divided by the FRCpleth of \>10%
CF children "without gas trapping" will be defined by a ratio between the difference of the functional residual capacity (FRC) obtained by plethysmography (FRCpleth) and FRC obtained by helium dilution method (FRCHe) divided by the FRCpleth of ≤10%
Capnography data included in Lung Clearance Index measurement (a pulmonary function test included in routinely yearly follow-up of cystic fibrosis children) will be collected and analyzed
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children are recruited from subjects diagnosed with cystic fibrosis followed-up at the pediatric reference center of University Children's Hospital of Nancy and Trousseau of Paris (46 children from Nancy and 30 children from Paris). These children are referred by the pneumopediatricians to the Pediatric Pulmonary Function Testing Lab for a complete, annually, routinely follow-up assessment of respiratory function. An analysis of the capnography data included in the Lung Clearance Index measurement, which is part of the routine assessment of the CF child, will be performed. The complete routine yearly PFT in order to ensure the follow-up in CF children is composed of 4 techniques: measurement of lung volumes by plethysmography (1), measurement of lung volumes by helium dilution technique (2); LCI measurement (3); spirometry (4). The outcomes needed for this research are obtained by these techniques.
CHRU de NANCY
Nancy, 54035, France
Hôpital ARMAND TROUSSEAU
Paris, 75571, France
Robinson PD, Latzin P, Ramsey KA, Stanojevic S, Aurora P, Davis SD, Gappa M, Hall GL, Horsley A, Jensen R, Lum S, Milla C, Nielsen KG, Pittman JE, Rosenfeld M, Singer F, Subbarao P, Gustafsson PM, Ratjen F; ATS Assembly on Pediatrics. Preschool Multiple-Breath Washout Testing. An Official American Thoracic Society Technical Statement. Am J Respir Crit Care Med. 2018 Mar 1;197(5):e1-e19. doi: 10.1164/rccm.201801-0074ST.
BEDELL GN, MARSHALL R, DUBOIS AB, COMROE JH. Plethysmographic determination of the volume of gas trapped in the lungs. J Clin Invest. 1956 Jun;35(6):664-70. doi: 10.1172/JCI103323. No abstract available.
First Submitted
March 18, 2021
First Posted
March 24, 2021
Study Start
May 5, 2021
Actual (reported)Primary Completion
October 30, 2021
Estimated (date passed)Contact the study team to confirm eligibility.
Kraemer R, Schoni MH. Ventilatory inequalities, pulmonary function and blood oxygenation in advanced states of cystic fibrosis. Respiration. 1990;57(5):318-24. doi: 10.1159/000195864.
O'Donnell CR, Bankier AA, Stiebellehner L, Reilly JJ, Brown R, Loring SH. Comparison of plethysmographic and helium dilution lung volumes: which is best for COPD? Chest. 2010 May;137(5):1108-15. doi: 10.1378/chest.09-1504. Epub 2009 Dec 18.
Jarenback L, Tufvesson E, Ankerst J, Bjermer L, Jonson B. The Efficiency Index (EFFi), based on volumetric capnography, may allow for simple diagnosis and grading of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 27;13:2033-2039. doi: 10.2147/COPD.S161345. eCollection 2018.
Ioan I, Demoulin B, Duvivier C, Leblanc AL, Bonabel C, Marchal F, Schweitzer C, Varechova S. Frequency dependence of capnography in anesthetized rabbits. Respir Physiol Neurobiol. 2014 Jan 1;190:14-9. doi: 10.1016/j.resp.2013.09.002. Epub 2013 Sep 12.
Gustafsson PM, Aurora P, Lindblad A. Evaluation of ventilation maldistribution as an early indicator of lung disease in children with cystic fibrosis. Eur Respir J. 2003 Dec;22(6):972-9. doi: 10.1183/09031936.03.00049502.
You B, Peslin R, Duvivier C, Vu VD, Grilliat JP. Expiratory capnography in asthma: evaluation of various shape indices. Eur Respir J. 1994 Feb;7(2):318-23. doi: 10.1183/09031936.94.07020318.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 30, 2021
Record last verified: 2021-07
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