Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 1:58 PM
Study NCT ID:
NCT00922350
Status:
COMPLETED
Last Update Posted:
2009-06-17
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heliox and Posture in Patients With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C038949', 'term': 'heliox'}, {'id': 'C095714', 'term': 'MUSK protein, human'}, {'id': 'D010100', 'term': 'Oxygen'}, {'id': 'C484532', 'term': 'NPSR1 protein, human'}, {'id': 'D011187', 'term': 'Posture'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-16', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spirometry', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': '6 months'}, {'measure': 'Peripheral oxygen saturation', 'timeFrame': '6 months'}, {'measure': 'Borg scale', 'timeFrame': '6 months'}, {'measure': 'Heart rate', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['asthma', 'heliox', 'bronchodilators', 'posture'], 'conditions': ['Acute Asthma']}, 'referencesModule': {'references': [{'pmid': '10453854', 'type': 'RESULT', 'citation': 'Kass JE, Terregino CA. The effect of heliox in acute severe asthma: a randomized controlled trial. Chest. 1999 Aug;116(2):296-300. doi: 10.1378/chest.116.2.296.'}, {'pmid': '16723037', 'type': 'RESULT', 'citation': 'Hess DR, Fink JB, Venkataraman ST, Kim IK, Myers TR, Tano BD. The history and physics of heliox. Respir Care. 2006 Jun;51(6):608-12.'}, {'pmid': '9925082', 'type': 'RESULT', 'citation': 'Hess DR, Acosta FL, Ritz RH, Kacmarek RM, Camargo CA Jr. The effect of heliox on nebulizer function using a beta-agonist bronchodilator. Chest. 1999 Jan;115(1):184-9. doi: 10.1378/chest.115.1.184.'}, {'pmid': '10471601', 'type': 'RESULT', 'citation': 'Gorini M, Iandelli I, Misuri G, Bertoli F, Filippelli M, Mancini M, Duranti R, Gigliotti F, Scano G. Chest wall hyperinflation during acute bronchoconstriction in asthma. Am J Respir Crit Care Med. 1999 Sep;160(3):808-16. doi: 10.1164/ajrccm.160.3.9712088.'}, {'pmid': '21352660', 'type': 'DERIVED', 'citation': 'Brandao DC, Britto MC, Pessoa MF, de Sa RB, Alcoforado L, Matos LO, Silva TN, de Andrade AD. Heliox and forward-leaning posture improve the efficacy of nebulized bronchodilator in acute asthma: a randomized trial. Respir Care. 2011 Jul;56(7):947-52. doi: 10.4187/respcare.00963. Epub 2011 Feb 21.'}], 'seeAlsoLinks': [{'url': 'http://www.ufpe.br', 'label': 'Federal University of Pernambuco'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack.', 'detailedDescription': 'When associated with inhaled bronchodilators, the heliox, a mixture of helium and oxygen in obstructive lung diseases with asthma, reduces the turbulence of airflow despite high rates, due to its low density.\n\nAlthough the first report of the use of heliox in the treatment of asthma dating to 1935, few controlled studies are available clarify the impact of the use of heliox in hospital admission of patients with acute asthma attacks refractory to standard treatment.\n\nThe severe airflow obstruction, observed in cases of acute asthma, also leads to lung hyperinflation that favors the increase of respiratory work by increasing the load for the inspiratory muscles by placing them at a mechanical disadvantage.\n\nVarious body positions were studied relating them to muscle activity with mechanical disadvantage. These studies suggest that the influence posture acts mainly in the position of the diaphragm, thus, increasing the stress related to other muscles such as the abdominals and the effect of gravity on these.\n\nThis study aims to: assess the efficiency of the positioning body associated with nebulization with bronchodilators carried by heliox during acute severe asthma in adults, using as the primary outcomes FEV1, FVC and PEF and secondary outcomes as the Borg scale, inspiratory capacity, RR, HR and SpO2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* reversibility of bronchial obstruction after administration of bronchodilator drugs for at least 10% in FEV1\n* a clinical diagnosis of acute severe asthma\n* a history of asthma over 1 year\n* duration of the crisis of current asthma lasting less than seven days\n\nExclusion Criteria:\n\n* were unable to understand or perform the spirometric maneuver\n* smoking (within the last 3 years associated with a higher consumption of 100 cigarettes/year)\n* other pulmonary comorbidities\n* lower to upper airways\n* heart failure\n* heart rate greater than 150 bpm\n* systolic pressure below 90 mmHg or greater than 150 MHG\n* pregnancy\n* inability to stay inline with the trunk forward'}, 'identificationModule': {'nctId': 'NCT00922350', 'briefTitle': 'Heliox and Posture in Patients With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.', 'orgStudyIdInfo': {'id': '2525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'heliox', 'description': 'The patients in this group underwent nebulization with heliox carried by the trunk erect', 'interventionNames': ['Other: HELIOX']}, {'type': 'EXPERIMENTAL', 'label': 'heliox+posture', 'description': 'The patients in this group carried out the mist carried by heliox and the trunk tilted forward', 'interventionNames': ['Other: HELIOX+POSTURE']}, {'type': 'EXPERIMENTAL', 'label': 'oxygen+posture', 'description': 'The patients in this group carried out the mist carried by oxygen and the trunk tilted forward', 'interventionNames': ['Other: OXYGEN + POSTURE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oxygen', 'description': 'The patients in this group carried out the mist carried by the oxygen and the trunk upright', 'interventionNames': ['Other: OXYGEN']}], 'interventions': [{'name': 'HELIOX', 'type': 'OTHER', 'otherNames': ['asma'], 'description': 'The nebulization was conducted in the same way that heliox + posture group, except the attitude of trunk, where the patients in this group did the Nebulizer with the trunk upright.', 'armGroupLabels': ['heliox']}, {'name': 'OXYGEN', 'type': 'OTHER', 'otherNames': ['ASTHMA', 'NEBULIZATION'], 'description': 'The NEBULIZATION was performed the same way as the heliox group, except for torso posture, where the patients in this group with the trunk upright Nebulizer Oxygen for cars have A NEBULIZATION.', 'armGroupLabels': ['oxygen']}, {'name': 'HELIOX+POSTURE', 'type': 'OTHER', 'otherNames': ['heliox', 'posture', 'physioterapy'], 'description': 'Patients underwent two carried by heliox nebulization associated with fenoterol (2.5 mg) and ipratropium bromide (0.25 mg). We used three ml of saline solution at 0.9%. For nebulization with heliox or oxygen, was used a system of distribution not invasive, semi-closed in a mask that is non toxic connected to a piece "Y" with a nebulizer in a follow and a bag of tank with a capacity for 2.5 L in the other connected with a valve action. This system was used so that there was a dilution gas. The proportion of 80:20 heliox was used (80% helium: 20% oxygen). To postural change in groups and heliox Oxygen + posture + posture, oriented to the participants to maintain an angle of inclination of the trunk and elbows supported on the thighs, measured from the anterior axillary line and lateral epicondyle of the femur, between 50th and 60th .', 'armGroupLabels': ['heliox+posture']}, {'name': 'OXYGEN + POSTURE', 'type': 'OTHER', 'otherNames': ['POSTURE', 'PHYSIOTERAPY', 'ASTHMA'], 'description': 'The NEBULIZATION was conducted in the same way that heliox + posture GROUP, however the patients in this group have the Oxygen for Carr A NEBULIZATION', 'armGroupLabels': ['oxygen+posture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Barros Lima Policlinic', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'overallOfficials': [{'name': 'Armele Andrade', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal de Pernambuco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Daniella Cunha Brandão', 'oldOrganization': 'Department of Physiotherapy'}}}}