Heliox and Posture in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT00922350
First received: June 8, 2009
Last updated: June 16, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Acute Asthma
Other: HELIOX
Other: OXYGEN
Other: HELIOX+POSTURE
Other: OXYGEN + POSTURE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • Spirometry [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Respiratory rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Peripheral oxygen saturation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Borg scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Heart rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: heliox
The patients in this group underwent nebulization with heliox carried by the trunk erect
Other: HELIOX
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.
Other Names:
  • heliox
  • asma
Experimental: heliox+posture
The patients in this group carried out the mist carried by heliox and the trunk tilted forward
Other: HELIOX+POSTURE
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 .
Other Names:
  • heliox
  • posture
  • physioterapy
Experimental: oxygen+posture
The patients in this group carried out the mist carried by oxygen and the trunk tilted forward
Other: OXYGEN + POSTURE
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
Other Names:
  • POSTURE
  • PHYSIOTERAPY
  • ASTHMA
Active Comparator: oxygen
The patients in this group carried out the mist carried by the oxygen and the trunk upright
Other: OXYGEN
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.
Other Names:
  • OXYGEN
  • ASTHMA
  • NEBULIZATION

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922350

Locations
Brazil
Barros Lima Policlinic
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Study Director: Armele Andrade Universidade Federal de Pernambuco
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniella Cunha Brandão, Department of Physiotherapy
ClinicalTrials.gov Identifier: NCT00922350     History of Changes
Other Study ID Numbers: 2525
Study First Received: June 8, 2009
Last Updated: June 16, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Universidade Federal de Pernambuco:
asthma
heliox
bronchodilators
posture

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014