Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation

Asthma Clinical Trial

— NV  

Official title:

Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012050
• Other study ID #: VNI1972NEB
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: November 10, 2009
• Start date: June 2007
• Est. completion date: January 2008

Study information

• Verified date: November 2009
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• NV
Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm)

Other:
• NEB group
Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm

Locations

Country	Name	City	State
Brazil	Valdecir Castor Galindo Filho	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

França 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. Epub 2005 Aug 31. — View 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. Epub 2008 Mar 17. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary characteristics		6 months	Yes
Secondary	Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance.		6 months	Yes

External Links

•   Link
•   Link