Use of Capnography for the Follow-up of Cystic Fibrosis Children

NCT04814797 | Unknown

• 1 other identifier: 2020PI150
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• to compare the other capnographic indices between CF children "with gas trapping" and CF children "without gas trapping": the slope of the ascending phase, α; the slope of the alveolar plateau, β; the angle Q between α and β; the positive peak of the first-order derivative, F'CO2, which reflects the ascending phase; the first negative peak of the 2nd order derivative, F "CO2, which reflects the curvature between the ascending phase and the alveolar plateau.
• to compare the results of the capnographic indices with the results of the FEV1 in identifying the presence / absence of "gas trapping";
• to compare the results of the capnographic indices with the results of the LCI in identifying the presence / absence of "gas trapping"

Conditions

Cystic Fibrosis

Keywords

Pulmonary function testing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

CF children "with gas trapping"

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%

Other: Capnography data included in Lung Clearance Index measurement

CF children "without gas trapping"

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%

Other: Capnography data included in Lung Clearance Index measurement

Interventions

Capnography data included in Lung Clearance Index measurement OTHER

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

CF children "with gas trapping"; CF children "without gas trapping"

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• child aged 6 to 17 inclusive;
• child diagnosed with cystic fibrosis (CF) and follow-up at the pediatric reference center of University Children's Hospitals of Nancy and Trousseau Hospital in Paris
• child for whom data from a complete routinely pulmonary function testing are available
• child who did not object to his/her participation
• child whose parental authority have received full information on the current research and have not objected to the participation of their child

You may not qualify if:

• other chronic respiratory pathology (bronchopulmonary dysplasia, virosis sequelae, inhalation pathology, thoraco-pulmonary malformation, tracheomalacia);
• anatomical or functional abnormalities of the pharyngolaryngeal pathway (tonsils hypertrophy grade 3 or 4, laryngomalacia, subglottic stenosis, vocal cord paralysis, any other laryngeal obstacle);
• congenital or acquired heart disease.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

CHRU de NANCY

Nancy, 54035, France

NOT YET RECRUITING

Hôpital ARMAND TROUSSEAU

Paris, 75571, France

RECRUITING

Related Publications (8)

• 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.

  PMID: 29493315 BACKGROUND

• 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.

  PMID: 13319505 BACKGROUND

• 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.

  PMID: 2284509 BACKGROUND

• 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.

  PMID: 20022972 BACKGROUND

• 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.

  PMID: 29988757 BACKGROUND

• 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.

  PMID: 24035836 BACKGROUND

• 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.

  PMID: 14680088 BACKGROUND

• 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.

  PMID: 8162985 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Iulia Ioan, MD PhD

CONTACT

+33 3 83 15 47 94; ic.ioan@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 24, 2021
• Study Start: May 5, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Locations

FR (2)