Clinical trial NCT06652542: Asthma Exacerbations & Respiratory Management International Survey
Official title: Asthma Exacerbations & Respiratory Management: an International Online Survey Endorsed by the International Association of Non-invasive Ventilation & International College of Experts
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Asthma Exacerbations
Keywords: Asthma Exacerbations
International Survey
Attitudes and Preferences
International Association of Non-invasive Ventilation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonologists, internists, paediatricians, and intensivists at primary, secondary, or tertiary health care facility, from different countries and geographic territories, with varying years of experience and academic backgrounds

Brief summary: Asthma is a chronic health condition that affects 300 million humans worldwide and is thought to cause around 1.000 deaths per day. It's estimated that asthma leads to a significant increase in disability adjusted life years (DALYs). Acute asthma exacerbations affect 25-56% of patients with asthma and represent 8% of intensive care unit (ICU) admissions. Acute asthma exacerbations continue to burden different health systems, particularly emergency units and intensive care units, despite vast advances in pharmacological treatment of asthma, development of evidence-based clinical practice guidelines to improve care of asthma.

This alarming situation indicates non-consensus regarding the best approach for managing acute exacerbations of asthma. Despite that variations in clinical practice regarding diagnosis, prevention, education, long-term management and symptom control of asthma have been thoroughly studied globally, less light has been shed on divergence of physicians' approaches when encountering asthmatic patients during acute exacerbations.

Detailed description: Aim of the Study:

Exploring the physicians' knowledge, attitude and current clinical, pharmacological and ventilatory management practices for acute asthma exacerbations.

Methodology:

Study Design:

The survey is intended to be a cross-sectional survey study.

Time Period:

February 2024-February 2025.

Study Settings:

Respondents are to be recruited by the authors, who are to distribute the online survey to targeted colleagues within the medical institutions the authors are affiliated to, and through different national and international scientific societies of common interest in pulmonology and critical care medicine. Individual physicians are free to distribute the online questionnaire form via electronic communication through the channels they deem most appropriate.

Target Respondents:

Physicians involved in the care of adult asthmatic patients (general practitioners, family medicine doctors, internists, pulmonologists, intensivists in different medical ICUs).

Development of the Questionnaire Questions:

First, a thorough revision of existing literature related to different aspects of management of asthma exacerbations was performed. A total of 45 articles published in national and international journals -including review articles, clinical trials, editorials, and meta-analyses-discussing diagnosis, severity assessment, pharmacological and ventilatory management, as well as outcomes of acute asthma exacerbations were examined to find points of variation in clinical practice, distinguish which approaches are evidence-based, and the magnitude and the pattern of deviation from clinical practice guidelines in different countries. Then, data to be explored were organized into seven domains:

Domain 1.: Respondents' characteristics:

This includes age, geographic region, specialty, years of experience, clinical position and academic degree (if present), affiliation, as well as the level of the health care facility through which a respondent provides care to patients presenting with acute asthma exacerbations.

Domain 2.: Diagnosis of acute asthma exacerbations:

Respondents are to report whether their reliance is wholly on clinical judgement or on tools provided by certain local or international practice guidelines when it comes to identifying asthma patients in acute exacerbations and deciding upon emergency room (ER) admission or ICU referral.

Domain 3.: Pharmacological Management of Acute Asthma Exacerbations:

This domain aims to measure the respondents' knowledge about different pharmacological therapies administrated during acute asthma exacerbations, their usual practice as governed by local policies and resources, as well as their individual preferences towards certain approaches, to detect gaps between knowledge and practice. Drugs including bronchodilators, systemic steroids, antibiotics, and anti-histaminic are to be inquired about regarding frequency of use, method of administration, prescribed doses, and ideal/preferred alternatives. Use of other drugs like magnesium sulphate, theophylline, epinephrine, inhaled anesthetics and intravenous ketamine is to be verified, and respondents are asked to report their knowledge about whether the use of any of these drugs is endorsed by any clinical practice guidelines they are aware of.

Domain 4.: Oxygen therapy during acute asthma exacerbations:

This domain screens the knowledge of the respondents about indications of oxygen administration during acute asthma exacerbations, explores their attitude towards the choice of oxygen delivery system. Familiarity of respondents with the settings of high-flow nasal cannula (HFNC), barriers towards its use, as well as physicians' preferences regarding HFNC are also explored.

Domain 5.: Non-invasive ventilation (NIV) in acute asthma exacerbations:

Access to NIV, frequency of its use, the available NIV devices, and the preferred NIV mode and interfaces by a respondent are inquired about. Respondents' knowledge of the physiological rationales behind using NIV, the appropriate settings of NIV for patients presenting with acute asthma exacerbations, and how to address the main problems arising in such patients are challenged. Knowledge, attitudes and respondents' preferences towards use of sedation during NIV in critically ill asthmatics, knowledge of the best approach to deliver nebulized drugs during NIV, understanding of NIV interference with nebulization therapy, as well as individual preferences regarding the method of delivery are all explored. Barriers to the use of NIV for acute asthma exacerbations, and potential complications associated with its application are also investigated.

Domain 6.: Invasive mechanical ventilation (IMV)in acute asthma exacerbations:

Respondents are inquired about frequency of application of IMV in acute asthma exacerbations, the units where IMV is provided, their knowledge about pathophysiology of severe asthma exacerbations, the appropriate mode and settings of MV, the role of sedation and neuromuscular blockade and the respondents' attitudes and preferences towards the use of these drugs and monitoring patients whilst administration of these drugs are explored. Adjustment of ventilatory settings prior to administration of nebulized drugs and frequency of complications during IMV of acute asthma exacerbations are inquired about as well.

Domain 7.: Outcomes of acute asthma exacerbations:

Respondents' knowledge about possible predictors of prognosis of patients presenting with asthma exacerbations is assessed.

Ethical Considerations:

No ethical approval by certain medical ethics commissions is required for this study. However, the online questionnaire form includes a consent statement at the start of the questionnaire that states a declaration of consent and that the respondent is a medical doctor who holds at least a graduate degree in medical science. Answering "yes" leads the respondent to the first domain, while answering "no" automatically leads the respondent to the end of the form to be submitted.

Data Storage and Confidentiality:

Contact information, i.e. e-mail address is set to be optional. Other personal information such as age, years of experience and affiliation are to be collected for the descriptive purposes and depiction of general characteristics of the respondents providing information but are not to be unlawfully shared or distributed. Access to such information is set to be exclusively restricted to the authors of the questionnaire form. After data analysis, results will be published -maintaining respondents' anonymity- and will be available upon request.

Management of Adverse Events:

Given the commitment of the authors to respondents' confidentiality, no adverse events are expected from this study.

Statistical Analysis:

A certified epidemiologist statistician is to help with statistical analysis. Descriptive statistics will be conducted as well as relevant inferential statistics.

Eligibility criteria: Inclusion Criteria:

* All practicing physician who may encounter patients with asthma during their clinical practice are invited to participate.

Exclusion Criteria:

* Non-practicing undergraduate medical students

Primary outcomes:
measure: Physicians Knowledge & Attitudes: Diagnosis of Asthma Exacerbations
timeFrame: Through study completion i.e. over an average of 1 year
measure: Physicians' Knowledge and Attitudes: Pharmacological Management
timeFrame: Through study completion i.e. over an average of 1 year
measure: Physicians Knowledge & Attitudes: Ventilatory Management
timeFrame: Through study completion i.e. over an average of 1 year
Secondary outcomes:
measure: Physicians' Knowledge: Prognosis of Acute Asthma Exacerbations
timeFrame: Through study completion i.e. over an average of 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
state: Assiut Governorate
Study officials:
affiliation: International Council Respiratory Care, ICU, Hospital Morales Meseguer, Murcia, Spain.
name: Antonio M. Esquinas, PhD, FCCP
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohammed M. Metwally, PhD, FCCR
role: STUDY_DIRECTOR
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