Heliox and Posture in Patients With Asthma

Acute Asthma Clinical Trial

Official title:

Heliox and Posture Optimize Action of Nebulization With Bronchodilators for Asthma Attacks. Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922350
• Other study ID #: 2525
• Status: Completed
• Phase: N/A
• First received: June 8, 2009
• Last updated: June 16, 2009
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Asthma
• Asthma

Intervention

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.
• 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.
• 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 .
• 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

Locations

Country	Name	City	State
Brazil	Barros Lima Policlinic	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View 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. Review. — View Citation

Kass JE, Terregino CA. The effect of heliox in acute severe asthma: a randomized controlled trial. Chest. 1999 Aug;116(2):296-300. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometry		6 months	Yes
Secondary	Respiratory rate		6 months	Yes
Secondary	Peripheral oxygen saturation		6 months	Yes
Secondary	Borg scale		6 months	Yes
Secondary	Heart rate		6 months	Yes

External Links

•   Federal University of Pernambuco