asal High Flow Versus Conventional Therapy in Emergency Department Patients With Asthma Exacerbation: A Randomized Controlled Trial

Phase 2

• Conditions: Acute asthma exacerbation; asthma attack; acute severe asthma; asthma exacerbation

• Registration Number: TCTR20210416004
• Lead Sponsor: Siriraj Research and Development Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-16
• Study Completion: 2023-04-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Patients with age of 18 years or older
2.Patients previously diagnosed with asthma according to GINA guideline6
3.Patients who present with symptoms compatible with exacerbation according to GINA guideline6 (progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function)
4.Patients who are still eligible meeting the above three criteria after initial standard management for 60 minutes

Exclusion Criteria

1.Patients with respiratory failure; defined as respiratory rate > 35 breaths/min, SpO2 < 90% despite oxygen supplement or signs of increased work of breathing, as observed by use of accessory muscles and abdominal asynchrony.
2.Patients with hemodynamic compromise (blood pressure < 90/60 mmHg) despite intravenous fluid resuscitation
3.Patients with a Glasgow Coma Scale score less than 13
4.Patients with contraindications to the use of equipment with positive airway pressure
5.Patients previously diagnosed with COPD or other chronic lung disease such as interstitial lung disease
6.Patients previously smoking > 5 pack/year
7.Patients concurrently diagnosed with other lower airway conditions such as pneumonia, pulmonary edema
8.Patients who decline to participate
9.Pregnant patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the degree of dyspnea measured with modified Borg scale 2 hours Questionnaire completed by the participant

Secondary Outcome Measures

Name	Time	Method
the degree of dyspnea measured with numeric rating scale 2 hours Questionnaire completed by the participant,Respiratory rate 2 hours automated machine,oxygen saturation 2 hours automated machine,end-tidal carbondioxide 2 hours automated machine,pulse rate 2 hours automated machine,blood pressure 2 hours automated machine,the degree of dyspnea measured with visual analog scale 2 hours rate by the study investigators,peak expiratory flow rate 2 hours peak flow meter,treatment escalation 24 hours prospective observation,Adverse events hospital stay prospective observation,length of stay hospital stay prospective observation