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Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation (NV)

U

Universidade Federal de Pernambuco

Status

Completed

Conditions

Asthma

Treatments

Device: NV
Other: NEB group

Study type

Interventional

Funder types

Other

Identifiers

NCT01012050
VNI1972NEB

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

39 participants in 2 patient groups

NV Group
Experimental group
Description:
Performed nebulization coupled with noninvasive ventilation
Treatment:
Device: NV
NEB group
Active Comparator group
Description:
Performed nebulization alone.
Treatment:
Other: NEB group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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