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

Not Applicable

Not yet recruiting

• Conditions: Asthma Exacerbation; Nebulization; Emergency Department
• Interventions: Device: Intermittent nebulization; Device: continuous nebulization

• Registration Number: NCT06291740
• Lead Sponsor: Thammasat University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Study Start: 2024-04
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent nebulization	Intermittent nebulization	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
Continuous nebulization	continuous nebulization	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

Primary Outcome Measures

Name	Time	Method
Length of ED stay	through study completion, an average of 1 year	duration of ED management

Secondary Outcome Measures

Name	Time	Method
pulmonary function test	through study completion, an average of 1 year	Forced Expiratory Volume in one second(FEV1), Peak Expiratory Flow(PEF)