Heliox and Posture in Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922350
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : June 17, 2009
Information provided by:
Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
Acute Asthma Other: HELIOX Other: OXYGEN Other: HELIOX+POSTURE Other: OXYGEN + POSTURE Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Heliox

Arm Intervention/treatment
Experimental: heliox
The patients in this group underwent nebulization with heliox carried by the trunk erect
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 Name: asma

Experimental: heliox+posture
The patients in this group carried out the mist carried by heliox and the trunk tilted forward
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
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:

Active Comparator: oxygen
The patients in this group carried out the mist carried by the oxygen and 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.
Other Names:

Primary Outcome Measures :
  1. Spirometry [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Respiratory rate [ Time Frame: 6 months ]
  2. Peripheral oxygen saturation [ Time Frame: 6 months ]
  3. Borg scale [ Time Frame: 6 months ]
  4. Heart rate [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00922350

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

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daniella Cunha Brandão, Department of Physiotherapy Identifier: NCT00922350     History of Changes
Other Study ID Numbers: 2525
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009

Keywords provided by Universidade Federal de Pernambuco:

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