Clinical trial NCT00922350: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Asthma
Keywords: asthma
heliox
bronchodilators
posture
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spirometry
timeFrame: 6 months
Secondary outcomes:
measure: Respiratory rate
timeFrame: 6 months
measure: Peripheral oxygen saturation
timeFrame: 6 months
measure: Borg scale
timeFrame: 6 months
measure: Heart rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Barros Lima Policlinic
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Armele Andrade
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.