Is the raised volume rapid thoracic compression technique ready for use in clinical trials in infants with cystic fibrosis?

Journal of Cystic Fibrosis

Volumn 15, Issue 1, 2016, Pages 10-20

  Matecki, Stefan ^a   Kent, Lisa ^b,c   de Boeck, Kris ^d   Le Bourgeois, Muriel ^e   Zielen, Stefan ^f   Braggion, Cesare ^g   Arets, H G M ^h   Bradley, Judy ^b,c   Davis, Stephanie ⁱ   Sermet, Isabelle ^e,j   Reix, Philippe ^k,l  

^a MONTPELLIER UNIVERSITY HOSPITAL   (France)

^b UNIVERSITY OF ULSTER   (United Kingdom)

^c ROYAL GROUP OF HOSPITALS TRUST   (United Kingdom)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^e HÔPITAL NECKER ENFANTS MALADES   (France)

^f GOETHE UNIVERSITY   (Germany)

^g UNIVERSITY OF FLORENCE   (Italy)

^h UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

ⁱ Cystic Fibrosis Pediatric Centre   (United States)

^j UNIVERSITÉ PARIS DESCARTES   (France)

^k Centre National de Référence de la Rougeole CNR   (France)

^l UNIVERSITÉ LYON 1   (France)

more..

Author keywords

Clinical trials; Clinimetric properties; Cystic fibrosis; Infant pulmonary function; Raised volume rapid thoracic compression; Surrogate outcome

Indexed keywords

CLINICAL TRIAL (TOPIC); CONVERGENT VALIDITY; CYSTIC FIBROSIS; FORCED EXPIRATORY VOLUME; HUMAN; INFECTION; INFLAMMATION; LUNG FUNCTION; LUNG FUNCTION TEST; LUNG VOLUME; MEDICAL PROCEDURES; OUTCOME ASSESSMENT; PREDICTIVE VALIDITY; RAISED VOLUME RAPID THORACIC COMPRESSION TECHNIQUE; REFERENCE VALUE; REVIEW; VALIDITY; EUROPE; INFANT; MEDICAL SOCIETY; PATIENT ACUITY; PROCEDURES; STANDARDS;

CLINICAL TRIALS AS TOPIC; CYSTIC FIBROSIS; EUROPE; HUMANS; INFANT; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT ACUITY; RESPIRATORY FUNCTION TESTS; SOCIETIES, MEDICAL;

EID: 84959576858     PISSN: 15691993     EISSN: 18735010     Source Type: Journal    
DOI: 10.1016/j.jcf.2015.03.015     Document Type: Review

References (40)

1. Stocks J., Thia L.P., Sonnappa S. Evaluation and use of childhood lung function tests in cystic fibrosis. Curr Opin Pulm Med 2012, 18:602-608.
2. Subbarao P., Stanojevic S., Brown M., Jensen R., Rosenfeld M., Davis S., et al. Lung clearance index as an outcome measure for clinical trials in young children with cystic fibrosis. A pilot study using inhaled hypertonic saline. Am J Respir Crit Care Med 2013, 188:456-460.
3. Bakker E.M., van der Meijden J.C., Nieuwhof E.M., Hop W.C., Tiddens H.A. Determining presence of lung disease in young children with cystic fibrosis: lung clearance index, oxygen saturation and cough frequency. J Cyst Fibros 2012, 11:223-230.
4. Davis S.D., Brody A.S., Emond M.J., Brumback L.C., Rosenfeld M. Endpoints for clinical trials in young children with cystic fibrosis. Proc Am Thorac Soc 2007, 4:418-430.
5. Rosenfeld M., Allen J., Arets B.H., Aurora P., Beydon N., Calogero C., et al. An official American Thoracic Society workshop report: optimal lung function tests for monitoring cystic fibrosis, bronchopulmonary dysplasia, and recurrent wheezing in children less than 6 years of age. Ann Am Thorac Soc 2013, 10:S1-S11.
6. Feher A., Castile R., Kisling J., Angelicchio C., Filbrun D., Flucke R., et al. Flow limitation in normal infants: a new method for forced expiratory maneuvers from raised lung volumes. J Appl Physiol 1996, 80:2019-2025.
7. Turner D.J., Lanteri C.J., LeSouef P.N., Sly P.D. Improved detection of abnormal respiratory function using forced expiration from raised lung volume in infants with cystic fibrosis. Eur Respir J 1994, 7:1995-1999.
8. ATS/ERS statement: raised volume forced expirations in infants: guidelines for current practice. Am J Respir Crit Care Med 2005, 172:1463-1471.
9. Frey U., Stocks J., Sly P., Bates J. Specification for signal processing and data handling used for infant pulmonary function testing. ERS/ATS Task Force on Standards for Infant Respiratory Function Testing. European Respiratory Society/American Thoracic Society. Eur Respir J 2000, 16:1016-1022.
10. Bates J.H., Schmalisch G., Filbrun D., Stocks J. Tidal breath analysis for infant pulmonary function testing. ERS/ATS Task Force on Standards for Infant Respiratory Function Testing. European Respiratory Society/American Thoracic Society. Eur Respir J 2000, 16:1180-1192.
11. Stocks J., Sly P.D., Morris M.G., Frey U. Standards for infant respiratory function testing: what(ever) next?. Eur Respir J 2000, 16:581-584.
12. De Boeck K., Kent L., Davies J., Derichs N., Amaral M., Rowe S.M., et al. CFTR biomarkers: time for promotion to surrogate end-point. Eur Respir J 2013, 41:203-216.
13. Subbarao P., Balkovec S., Solomon M., Ratjen F. Pilot study of safety and tolerability of inhaled hypertonic saline in infants with cystic fibrosis. Pediatr Pulmonol 2007, 42:471-476.
14. Ranganathan S.C., Hoo A.F., Lum S.Y., Goetz I., Castle R.A., Stocks J. Exploring the relationship between forced maximal flow at functional residual capacity and parameters of forced expiration from raised lung volume in healthy infants. Pediatr Pulmonol 2002, 33:419-428.
15. Lum S., Gustafsson P., Ljungberg H., Hulskamp G., Bush A., Carr S.B., et al. Early detection of cystic fibrosis lung disease: multiple-breath washout versus raised volume tests. Thorax 2007, 62:341-347.
16. Martinez T.M., Llapur C.J., Williams T.H., Coates C., Gunderman R., Cohen M.D., et al. High-resolution computed tomography imaging of airway disease in infants with cystic fibrosis. Am J Respir Crit Care Med 2005, 172:1133-1138.
17. Davis S.D., Rosenfeld M., Kerby G.S., Brumback L., Kloster M.H., Acton J.D., et al. Multicenter evaluation of infant lung function tests as cystic fibrosis clinical trial endpoints. Am J Respir Crit Care Med 2010, 182:1387-1397.
18. Hoo A.F., Thia L.P., Nguyen T.T., Bush A., Chudleigh J., Lum S., et al. Lung function is abnormal in 3-month-old infants with cystic fibrosis diagnosed by newborn screening. Thorax 2012, 67:874-881.
19. Lum S., Hoo A.F., Hulskamp G., Wade A., Stocks J. Potential misinterpretation of infant lung function unless prospective healthy controls are studied. Pediatr Pulmonol 2010, 45:906-913.
20. Linnane B.M., Hall G.L., Nolan G., Brennan S., Stick S.M., Sly P.D., et al. Lung function in infants with cystic fibrosis diagnosed by newborn screening. Am J Respir Crit Care Med 2008, 178:1238-1244.
21. Ranganathan S.C., Stocks J., Dezateux C., Bush A., Wade A., Carr S., et al. The evolution of airway function in early childhood following clinical diagnosis of cystic fibrosis. Am J Respir Crit Care Med 2004, 169:928-933.
22. Kozlowska W.J., Bush A., Wade A., Aurora P., Carr S.B., Castle R.A., et al. Lung function from infancy to the preschool years after clinical diagnosis of cystic fibrosis. Am J Respir Crit Care Med 2008, 178:42-49.
23. Nguyen T.T., Thia L.P., Hoo A.F., Bush A., Aurora P., Wade A., et al. Evolution of lung function during the first year of life in newborn screened cystic fibrosis infants. Thorax 2013, 69:910-917.
24. Pillarisetti N., Williamson E., Linnane B., Skoric B., Robertson C.F., Robinson P., et al. Infection, inflammation, and lung function decline in infants with cystic fibrosis. Am J Respir Crit Care Med 2011, 184:75-81.
25. Rosenfeld M., Ratjen F., Brumback L., Daniel S., Rowbotham R., McNamara S., et al. Inhaled hypertonic saline in infants and children younger than 6 years with cystic fibrosis: the ISIS randomized controlled trial. JAMA 2012, 307:2269-2277.
26. Nixon G.M., Armstrong D.S., Carzino R., Carlin J.B., Olinsky A., Robertson C.F., et al. Early airway infection, inflammation, and lung function in cystic fibrosis. Arch Dis Child 2002, 87:306-311.
27. Stick S., Tiddens H., Aurora P., Gustafsson P., Ranganathan S., Robinson P., et al. Early intervention studies in infants and preschool children with cystic fibrosis: are we ready?. Eur Respir J 2013, 42:527-538.
28. Peterson-Carmichael S.L., Harris W.T., Goel R., Noah T.L., Johnson R., Leigh M.W., et al. Association of lower airway inflammation with physiologic findings in young children with cystic fibrosis. Pediatr Pulmonol 2009, 44:503-511.
29. Patel K., Davis S.D., Johnson R., Esther C.R. Exhaled breath condensate purines correlate with lung function in infants and preschoolers. Pediatr Pulmonol 2013, 48:182-187.
30. Brumback L.C., Davis S.D., Kerby G.S., Kloster M., Johnson R., Castile R., et al. Lung function from infancy to preschool in a cohort of children with cystic fibrosis. Eur Respir J 2013, 41:60-66.
31. Rosenfeld M., Farrell P.M., Kloster M., Swanson J.O., Vu T., Brumback L., et al. Association of lung function, chest radiographs and clinical features in infants with cystic fibrosis. Eur Respir J 2013, 42:1545-1552.
32. Harrison A.N., Regelmann W.E., Zirbes J.M., Milla C.E. Longitudinal assessment of lung function from infancy to childhood in patients with cystic fibrosis. Pediatr Pulmonol 2009, 44:330-339.
33. Pittman J.E., Johnson R.C., Davis S.D. Improvement in pulmonary function following antibiotics in infants with cystic fibrosis. Pediatr Pulmonol 2012, 47:441-446.
34. Jones M., Castile R., Davis S., Kisling J., Filbrun D., Flucke R., et al. Forced expiratory flows and volumes in infants. Normative data and lung growth. Am J Respir Crit Care Med 2000, 161:353-359.
35. Castile R., Filbrun D., Flucke R., Franklin W., McCoy K. Adult-type pulmonary function tests in infants without respiratory disease. Pediatr Pulmonol 2000, 30:215-227.
36. Morris M.G. Comprehensive integrated spirometry using raised volume passive and forced expirations and multiple-breath nitrogen washout in infants. Respir Physiol Neurobiol 2010, 170:123-140.
37. Jones M.H., Davis S.D., Kisling J.A., Howard J.M., Castile R., Tepper R.S. Flow limitation in infants assessed by negative expiratory pressure. Am J Respir Crit Care Med 2000, 161:713-717.
38. Rosenfeld M., Davis S., Brumback L., Daniel S., Rowbotham R., Johnson R., et al. Inhaled hypertonic saline in infants and toddlers with cystic fibrosis: short-term tolerability, adherence, and safety. Pediatr Pulmonol 2011, 46:666-671.
39. Chudleigh J., Hoo A.F., Ahmed D., Prasad A., Sheehan D., Francis J., et al. Positive parental attitudes to participating in research involving newborn screened infants with CF. J Cyst Fibros 2013, 12:234-240.
40. Ranganathan S.C., Bush A., Dezateux C., Carr S.B., Hoo A.F., Lum S., et al. Relative ability of full and partial forced expiratory maneuvers to identify diminished airway function in infants with cystic fibrosis. Am J Respir Crit Care Med 2002, 166:1350-1357.