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Heliox and Posture in Patients With Asthma

Primary Purpose

Acute Asthma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
HELIOX
OXYGEN
HELIOX+POSTURE
OXYGEN + POSTURE
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Asthma focused on measuring asthma, heliox, bronchodilators, posture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Barros Lima Policlinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

heliox

heliox+posture

oxygen+posture

oxygen

Arm Description

The patients in this group underwent nebulization with heliox carried by the trunk erect

The patients in this group carried out the mist carried by heliox and the trunk tilted forward

The patients in this group carried out the mist carried by oxygen and the trunk tilted forward

The patients in this group carried out the mist carried by the oxygen and the trunk upright

Outcomes

Primary Outcome Measures

Spirometry

Secondary Outcome Measures

Respiratory rate
Peripheral oxygen saturation
Borg scale
Heart rate

Full Information

First Posted
June 8, 2009
Last Updated
June 16, 2009
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT00922350
Brief Title
Heliox and Posture in Patients With Asthma
Official Title
Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Although 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. The 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. Various 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. This 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Asthma
Keywords
asthma, heliox, bronchodilators, posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
heliox
Arm Type
Experimental
Arm Description
The patients in this group underwent nebulization with heliox carried by the trunk erect
Arm Title
heliox+posture
Arm Type
Experimental
Arm Description
The patients in this group carried out the mist carried by heliox and the trunk tilted forward
Arm Title
oxygen+posture
Arm Type
Experimental
Arm Description
The patients in this group carried out the mist carried by oxygen and the trunk tilted forward
Arm Title
oxygen
Arm Type
Active Comparator
Arm Description
The patients in this group carried out the mist carried by the oxygen and the trunk upright
Intervention Type
Other
Intervention Name(s)
HELIOX
Other Intervention Name(s)
asma
Intervention 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.
Intervention Type
Other
Intervention Name(s)
OXYGEN
Other Intervention Name(s)
ASTHMA, NEBULIZATION
Intervention 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.
Intervention Type
Other
Intervention Name(s)
HELIOX+POSTURE
Other Intervention Name(s)
heliox, posture, physioterapy
Intervention 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 .
Intervention Type
Other
Intervention Name(s)
OXYGEN + POSTURE
Other Intervention Name(s)
POSTURE, PHYSIOTERAPY, ASTHMA
Intervention 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
Primary Outcome Measure Information:
Title
Spirometry
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Respiratory rate
Time Frame
6 months
Title
Peripheral oxygen saturation
Time Frame
6 months
Title
Borg scale
Time Frame
6 months
Title
Heart rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armele Andrade
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Study Director
Facility Information:
Facility Name
Barros Lima Policlinic
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
10453854
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.
Results Reference
result
PubMed Identifier
16723037
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.
Results Reference
result
PubMed Identifier
9925082
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.
Results Reference
result
PubMed Identifier
10471601
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.
Results Reference
result
PubMed Identifier
21352660
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.
Results Reference
derived
Links:
URL
http://www.ufpe.br
Description
Federal University of Pernambuco

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Heliox and Posture in Patients With Asthma

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