Heliox and Posture in Patients With Asthma
Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.
1 other identifier
interventional
59
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedJune 17, 2009
June 1, 2009
6 months
June 8, 2009
June 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spirometry
6 months
Secondary Outcomes (4)
Respiratory rate
6 months
Peripheral oxygen saturation
6 months
Borg scale
6 months
Heart rate
6 months
Study Arms (4)
heliox
EXPERIMENTALThe patients in this group underwent nebulization with heliox carried by the trunk erect
heliox+posture
EXPERIMENTALThe patients in this group carried out the mist carried by heliox and the trunk tilted forward
oxygen+posture
EXPERIMENTALThe patients in this group carried out the mist carried by oxygen and the trunk tilted forward
oxygen
ACTIVE COMPARATORThe patients in this group carried out the mist carried by the oxygen and the trunk upright
Interventions
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.
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.
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 .
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
Eligibility Criteria
You may qualify if:
- reversibility of bronchial obstruction after administration of bronchodilator drugs for at least 10% in FEV1
- a clinical diagnosis of acute severe asthma
- a history of asthma over 1 year
- duration of the crisis of current asthma lasting less than seven days
You may not qualify if:
- were unable to understand or perform the spirometric maneuver
- smoking (within the last 3 years associated with a higher consumption of 100 cigarettes/year)
- other pulmonary comorbidities
- lower to upper airways
- heart failure
- heart rate greater than 150 bpm
- systolic pressure below 90 mmHg or greater than 150 MHG
- pregnancy
- inability to stay inline with the trunk forward
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barros Lima Policlinic
Recife, Pernambuco, Brazil
Related Publications (5)
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: 10453854RESULTHess 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: 16723037RESULTHess 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: 9925082RESULTGorini 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: 10471601RESULTBrandao 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.
PMID: 21352660DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Armele Andrade
Universidade Federal de Pernambuco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 17, 2009
Study Start
June 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 17, 2009
Record last verified: 2009-06