Clinical trial NCT01012050: Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation
Official title: Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
status asthmatics
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2009-11-11
Enrollment: 39
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: Despite the physiologic and clinical effects provided by coupling nebulization with noninvasive ventilation in asthma exacerbation, there are few and controversial studies reported in the literature.

Detailed description: Reduced work of breathing, increased oxygenation and increased in expiratory peak flow (EPF) and forced expiratory volume in the first second (FEV1) are benefits of noninvasive ventilation (NV) in the treatment of asthma. Despite these clinical improvements attributed to NV during asthma exacerbations and the well-established effects of nebulization, there are few studies in the literature coupling both therapeutic resources.

In addition to this, no studies on scintigraphic analysis of radioaerosol deposition coupled with NV in asthmatics have published. A previous study was published by our group, but involved healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of moderate to severe asthma (FEV1 \< 60 % of predicted values)
* Breathing rate \> 25 bpm
* History of asthma for at least 1 year
* Duration of current asthma attack of \< 7 days
* Reversibility of FEV1 of at least ≤ 10% after the administration of bronchodilator drugs

Exclusion Criteria:

* Current smoker
* Presence of cardiopulmonary disease (COPD, pneumonia, heart failure, myocardial infarction, pneumothorax)
* Hyperthermia
* Indication of intubation and invasive mechanical ventilation;
* Hemodynamic instability (heart rate \> 150 bpm and systolic blood pressure \< 90 mmHg)
* Cardiac arrhythmia
* Changes in consciousness
* Pregnancy
* Contraindications to use NV

Primary outcomes:
measure: Cardiopulmonary characteristics
timeFrame: 6 months
Secondary outcomes:
measure: Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance.
timeFrame: 6 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Valdecir Castor Galindo Filho
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Valdecir C Galindo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018.
citation: Franca EE, Dornelas de Andrade AF, Cabral G, Almeida Filho P, Silva KC, Galindo Filho VC, Marinho PE, Lemos A, Parreira VF. Nebulization associated with bi-level noninvasive ventilation: analysis of pulmonary radioaerosol deposition. Respir Med. 2006 Apr;100(4):721-8. doi: 10.1016/j.rmed.2005.07.012. Epub 2005 Aug 31.
citation: Soma T, Hino M, Kida K, Kudoh S. A prospective and randomized study for improvement of acute asthma by non-invasive positive pressure ventilation (NPPV). Intern Med. 2008;47(6):493-501. doi: 10.2169/internalmedicine.47.0429. Epub 2008 Mar 17.
citation: Galindo-Filho VC, Brandao DC, Ferreira Rde C, Menezes MJ, Almeida-Filho P, Parreira VF, Silva TN, Rodrigues-Machado Mda G, Dean E, Dornelas de Andrade A. Noninvasive ventilation coupled with nebulization during asthma crises: a randomized controlled trial. Respir Care. 2013 Feb;58(2):241-9. doi: 10.4187/respcare.01371.