Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652542
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Asthma Exacerbations Respiratory Management International Survey
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Asthma Exacerbations Respiratory Management an International Online Survey Endorsed by the International Association of Non-invasive Ventilation International College of Experts
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AERMIS
Brief Summary:
Asthma is a chronic health condition that affects 300 million humans worldwide and is thought to cause around 1000 deaths per day Its 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
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 idealpreferred 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 IMVin 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 ie 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
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 idealpreferred 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 IMVin 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None