Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department

Thammasat University

Status: Not yet enrolling

Conditions: Emergency Department; Asthma Exacerbation; Nebulization

Treatments: Device: Intermittent nebulization; Device: continuous nebulization

Study type: Interventional

Funder types: Other

Identifiers

NCT06291740

MTU-EC-EM-2-008/67

Faculty of Medicine (Other Identifier)

Details and patient eligibility

About

The goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ED). Participants will random assign to either continuous or intermittent nebulization. In the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. In the intermittent group, the same medications are administer every 20 minutes for an hour. Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge. Adverse events are documented.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• asthma exacerbation

Exclusion criteria

• life-threatening conditions requiring intubation
• allergy to steroid or its components
• patient under investigation of Corona Virus Disease, 2019 (COVID-19)
• pulmonary tuberculosis
• unable to cooperate for pulmonary function testing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Continuous nebulization

Experimental group

Description:

continuous nebulization using the MiniHEART-HiFlo® nebulizer containing Budesonide 1000 microgram/2 ml (3 respules) + 1.25 mg of fenoterol and 0.5 mg of ipratropium bromide (Berodual®, 4 ml) and Normal saline 12 ml in the nebulizer chamber. Patients in this group will receive continuous aerosol therapy over a period of 1 hour at an oxygen flow rate of 8 L/min

Treatment:

Device: continuous nebulization

intermittent nebulization

Active Comparator group

Description:

intermittent nebulization using a nebulizer containing Budesonide 1000 microgram/2 ml (1 respules) + 1.25 mg of fenoterol and 0.5 mg of ipratropium bromide (Berodual®, 4 ml) at an oxygen flow rate of 10 L/min every 20 minutes, thrice within 1 hour

Treatment:

Device: Intermittent nebulization