Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NV Group

Performed nebulization coupled with noninvasive ventilation

Group Type EXPERIMENTAL

NV

Intervention Type DEVICE

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

NEB group

Performed nebulization alone.

Group Type ACTIVE_COMPARATOR

NEB group

Intervention Type OTHER

Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm

Interventions

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NV

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

Intervention Type DEVICE

NEB group

Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm

Intervention Type OTHER

Other Intervention Names

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Interventional Group Control group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No