Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Diaphragmatic Mobility, Lung Hyperinflation and Effects of the Pulmonary Rehabilitation
Verified date | August 2017 |
Source | Casa Di Cura Villa Serena SpA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine whether the COPD impairs the diaphragmatic mobility (DM), and verify
improvements after an inpatient pulmonary rehabilitation (PR).
Ultrasonography on M-mode will assess the diaphragmatic mobility at rest breathing and at
slow deep inspiration. Lung functions test, arterial blood gas analyses, six minute walk test
will be also performed, on COPD patients and healthy subjects.
Status | Completed |
Enrollment | 56 |
Est. completion date | December 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - Clinical Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) - Informed consent signature Exclusion Criteria: - Subjects with Pneumothorax - Subjects with Active hemoptyses - Subjects with Acute heart failure - Subjects with Systemic arterial hypertension - Subjects with aortic aneurism - Subjects who underwent Hepatic surgery - Subjects who underwent Splenectomy surgery - Subjects with Diaphragmatic paralysis Subjects with Neuromuscular diseases Subjects with Chronic orthopaedic diseases |
Country | Name | City | State |
---|---|---|---|
Italy | Casa di Cura Villa Serena | Piossasco |
Lead Sponsor | Collaborator |
---|---|
Casa Di Cura Villa Serena SpA |
Italy,
Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18. — View Citation
Cassart M, Pettiaux N, Gevenois PA, Paiva M, Estenne M. Effect of chronic hyperinflation on diaphragm length and surface area. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):504-8. — View Citation
Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schünemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008. — View Citation
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Mölken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570. — View Citation
Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diaphragmatic mobility | diaphragmatic craniocaudal displacement on centimeters (performed on M-mode, mobility measured on centimeters) | up to four weeks | |
Secondary | Lung function (Spirometry) | measurements of Forced vital capacity (liters), Forced expiratory volume on the first second (liters), expiratory reserve volume (liters), Inspiratory capacity (liters), Vital capacity (liters), Inspiratory reserve volume (liters), Tidal Volume (liters), | up to four weeks | |
Secondary | Lung function (Body plethysmography) | Total Lung capacity (liters), Total gas volume (liters), Residual volume (liters). | up to four weeks | |
Secondary | Lung function (gas exchange) | measurements of carbon monoxide lung diffusion (DLCO) on milliliters/minute/millimeters of mercury. | up to four weeks | |
Secondary | Functional status (Six minute walking test) | measurement of the distance walked (in meters) on six minutes | up to four weeks | |
Secondary | measurements of arterial blood gas | arterial blood sampling to measure hydrogenic potential (Ph), arterial oxygen pressure (PaO2), arterial carbonic anhydride pressure (PaCO2), bicarbonate (HCO3). PaO2, PaCO2 and HCO3 are measured on millimeters of mercury (mmHg) | up to four weeks |
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