Enhance Patient SafetyMMC26NCT07788690
Advanced Airway Management Among Primary Care Health
A study testing Educative Intervention in people with Enhance Patient Safety and Nurse Physician Relations, run by Universitat Jaume I at 1 site in Spain.
Trial summary
Background: Advanced airway management is a critical component of advanced life support (ALS). Supraglottic airway devices (SADs) represent an effective and safe alternative to endotracheal intubation in emergency settings, particularly in Primary Care (PC), where low exposure to critical situations favors skills… Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Enhance Patient Safety, Nurse Physician Relations, Physician-Nurse Relations
- What is being tested?
- Educative Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physicians and nurses with active employment contracts in primary care in the evaluated department.
- An employment contract or appointment lasting more than 6 months.
- Voluntary consent to participate
Who cannot join
- Doctors and nurses who were on temporary disability leave or leave of absence at the time of the study.
- Questionnaires that were duplicates or had any blank questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Needs in Advanced Airway Management Among Primary Care Health Professionals: a Cross-sectional Study on Knowledge, Self-perceived Competence, and Training Needs.
Background: Advanced airway management is a critical component of advanced life support (ALS). Supraglottic airway devices (SADs) represent an effective and safe alternative to endotracheal intubation in emergency settings, particularly in Primary Care (PC), where low exposure to critical situations favors skills decay. The objective is to analyze the baseline level of theoretical knowledge and self-perceived ability regarding SADs management among PC physicians and nurses.
Methods This quantitative cross-sectional study was conducted in primary care (PC) health centers within the Castellón Health Department, Spain. The study included 92 PC healthcare professionals. Data were collected using an ad hoc digital questionnaire that had previously been validated by 14 experts, achieving an overall Scale-level Content Validity Index (S-CVI) of 0.93. Descriptive and bivariate inferential analyses were performed using Pearson's chi-square test, Fisher's exact test, and the Mann-Whitney U test. Statistical significance was set at p ≤ 0.05.
Read the detailed description
BACKGROUND Out-of-hospital cardiopulmonary arrest (CPA) is one of the leading medical emergencies worldwide, with an incidence in Europe of approximately 55 cases per 100,000 inhabitants and an overall survival rate at hospital discharge of close to 8%. In Spain, the estimated incidence is around 25 cases per 100,000 inhabitants, with survival rates that remain moderate and are influenced by delays in the initiation of resuscitation and by the quality of initial advanced life support.
During Advanced Life Support (ALS), rapid and effective airway management is a critical factor in mitigating hypoxic brain injury. Although endotracheal intubation (ETI) has traditionally been considered the gold standard, its performance in out-of-hospital settings by non-anesthesiologists or practitioners with limited technical experience is associated with significant rates of failure, repeated attempts, and prolonged interruptions in chest compressions, which severely compromise coronary and cerebral perfusion. In this scenario, supraglottic devices (SGDs) have emerged as a priority first-line alternative that is safe and quick to insert, offering high success rates and minimizing pauses in cardiopulmonary resuscitation (CPR).
Current recommendations prioritize techniques that ensure effective ventilation while minimizing interruptions in chest compressions.
However, evidence indicates that a significant proportion of healthcare professionals have cognitive and competency deficits in the management of acute care. This situation is particularly relevant in primary care, where acute events are infrequent and opportunities for practical training are limited, which accelerates the phenomenon of skill decay.
Assessing baseline knowledge is a fundamental step in identifying actual training needs and designing tailored educational interventions. However, there is little evidence regarding the cognitive level of primary care professionals with respect to the management of DSG prior to receiving structured training-a key starting point for guiding competency-based programs and ensuring patient safety.
For all these reasons, the primary objective of this study was to assess the baseline level of theoretical knowledge regarding the management of DSG among primary care healthcare professionals (physicians and nurses) in the Castellón Department of Health. The following were set as secondary objectives:
- Describe the sociodemographic, academic, and employment profiles of the staff being evaluated.
- Identify specific conceptual gaps and common errors in ALS procedures related to the use of DSG.
- Analyze the statistical association between sociodemographic and professional variables and the success rate on the knowledge questionnaire.
- Assess professionals' self-perceived competence and compare it with their objective cognitive/theoretical performance.
- Being tested
- Educative Intervention
- Keywords
- Primary Health Care, Health Education, Supraglottic Airway Devices, Simulation, Airway Management
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educative InterventionOther
This is an educational intervention in which participants were provided with several sessions to recognize and better manage supraglottic devices.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention with pre-post intra-subject | Other | This is an educational intervention in which participants were provided with several sessions to recognize and better manage supraglottic devices. Receives: Other: Educative Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline level of theoretical knowledge regarding the management of DSG
Change from baseline level of theoretical knowledge regarding the management of DSG among primary care healthcare professionals (physicians and nurses) in the Castellón Department of Health.
Measured: From the enrollment to the end of first objective 6 weeks
Secondary outcomes (6)
Sociodemographic characteristics
Describe the sociodemographic profile of the staff being evaluated.
Measured: From the enrollment to the end of the intervention, 4 weeks
Sociodemographic characteristics
Describe the academic profile of the staff being evaluated.
Measured: From the enrollment to the end of the intervention, 4 weeks
Sociodemographic characteristics
Describe the employment profile of the staff being evaluated.
Measured: From the enrollment to the end of the intervention, 4 weeks
gaps and common errors in ALS procedures
Identify specific conceptual gaps and common errors in ALS procedures related to the use of DSG.
Measured: From the enrollment to the end of the intervention 4 weeks
statistical association between sociodemographic and professional variables
Analyze the statistical association between sociodemographic and professional variables and the success rate on the knowledge questionnaire.
Measured: From the enrollment to the end of the intervention, 8 weeks
Comparative
Assess professionals' self-perceived competence and compare it with their objective cognitive/theoretical performance.
Measured: From the enrollment to the end of the intervention, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enhance Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An observational, analytical, and cross-sectional study was conducted at primary care health centers under the Castellón Department of Health (Valencian Community, Spain). The target population consisted of 538 active healthcare professionals (family physicians and community nurses). The sample size was calculated using the G\*Power program (v. 3.1.9.7), which determined a minimum requirement of 96 participants to ensure 95% statistical power (α=0.05; moderate-to-low effect size d=0.30). The final sample consisted of 92 participants who validly completed the questionnaire, maintaining a statistical power of over 90%. Selection was based on non-probabilistic convenience sampling. The medical and nursing coordinators at each health center were contacted to distribute the digital questionnaires to the professionals. Professionals who met the inclusion criteria and voluntarily provided their consent to participate were included in the study.
- Masking
- None (open label)
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Jaume I, Spain, Generalitat Valenciana
- Responsible party
- Principal investigator, Isabel Almodóvar Fernández, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788690
- Sponsor's protocol ID
- UJI26-MMC
- Other IDs
- Ethics Commite CEISH/06/2024
- Acronym
- MMC26
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study is part of a doctoral thesis that will be defended in 2027.
Publications
10.1016/j.resuscitation.2021.02.007
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Needs in Advanced Airway Management Among Primary Care Health Professionals: a Cross-sectional Study on Knowledge, Self-perceived Competence, and Training Needs.
- ClinicalTrials.gov ID
- NCT07788690
- Acronym / sponsor ID
- MMC26 / UJI26-MMC
- Keywords
- Primary Health Care, Health Education, Supraglottic Airway Devices, Simulation, Airway Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Universitat Jaume I, Spain, Generalitat Valenciana
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Advanced airway management is a critical component of advanced life support (ALS). Supraglottic airway devices (SADs) represent an effective and safe alternative to endotracheal intubation in emergency settings, particularly in Primary Care (PC), where low exposure to critical situations favors skills decay. The objective is to analyze the baseline level of theoretical knowledge and self-perceived ability regarding SADs management among PC physicians and nurses.
Methods This quantitative cross-sectional study was conducted in primary care (PC) health centers within the Castellón Health Department, Spain. The study included 92 PC healthcare professionals. Data were collected using an ad hoc digital questionnaire that had previously been validated by 14 experts, achieving an overall Scale-level Content Validity Index (S-CVI) of 0.93. Descriptive and bivariate inferential analyses were performed using Pearson's chi-square test, Fisher's exact test, and the Mann-Whitney U test. Statistical significance was set at p ≤ 0.05.
Detailed description
BACKGROUND Out-of-hospital cardiopulmonary arrest (CPA) is one of the leading medical emergencies worldwide, with an incidence in Europe of approximately 55 cases per 100,000 inhabitants and an overall survival rate at hospital discharge of close to 8%. In Spain, the estimated incidence is around 25 cases per 100,000 inhabitants, with survival rates that remain moderate and are influenced by delays in the initiation of resuscitation and by the quality of initial advanced life support.
During Advanced Life Support (ALS), rapid and effective airway management is a critical factor in mitigating hypoxic brain injury. Although endotracheal intubation (ETI) has traditionally been considered the gold standard, its performance in out-of-hospital settings by non-anesthesiologists or practitioners with limited technical experience is associated with significant rates of failure, repeated attempts, and prolonged interruptions in chest compressions, which severely compromise coronary and cerebral perfusion. In this scenario, supraglottic devices (SGDs) have emerged as a priority first-line alternative that is safe and quick to insert, offering high success rates and minimizing pauses in cardiopulmonary resuscitation (CPR).
Current recommendations prioritize techniques that ensure effective ventilation while minimizing interruptions in chest compressions.
However, evidence indicates that a significant proportion of healthcare professionals have cognitive and competency deficits in the management of acute care. This situation is particularly relevant in primary care, where acute events are infrequent and opportunities for practical training are limited, which accelerates the phenomenon of skill decay.
Assessing baseline knowledge is a fundamental step in identifying actual training needs and designing tailored educational interventions. However, there is little evidence regarding the cognitive level of primary care professionals with respect to the management of DSG prior to receiving structured training-a key starting point for guiding competency-based programs and ensuring patient safety.
For all these reasons, the primary objective of this study was to assess the baseline level of theoretical knowledge regarding the management of DSG among primary care healthcare professionals (physicians and nurses) in the Castellón Department of Health. The following were set as secondary objectives:
- Describe the sociodemographic, academic, and employment profiles of the staff being evaluated.
- Identify specific conceptual gaps and common errors in ALS procedures related to the use of DSG.
- Analyze the statistical association between sociodemographic and professional variables and the success rate on the knowledge questionnaire.
- Assess professionals' self-perceived competence and compare it with their objective cognitive/theoretical performance.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An observational, analytical, and cross-sectional study was conducted at primary care health centers under the Castellón Department of Health (Valencian Community, Spain). The target population consisted of 538 active healthcare professionals (family physicians and community nurses). The sample size was calculated using the G*Power program (v. 3.1.9.7), which determined a minimum requirement of 96 participants to ensure 95% statistical power (α=0.05; moderate-to-low effect size d=0.30). The final sample consisted of 92 participants who validly completed the questionnaire, maintaining a statistical power of over 90%. Selection was based on non-probabilistic convenience sampling. The medical and nursing coordinators at each health center were contacted to distribute the digital questionnaires to the professionals. Professionals who met the inclusion criteria and voluntarily provided their consent to participate were included in the study.
| Arm | Type | Receives |
|---|---|---|
| Educational intervention with pre-post intra-subject | Other | Other: Educative InterventionThis is an educational intervention in which participants were provided with several sessions to recognize and better manage supraglottic devices. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physicians and nurses with active employment contracts in primary care in the evaluated department.
- An employment contract or appointment lasting more than 6 months.
- Voluntary consent to participate
Key exclusion criteria (2 listed)
- Doctors and nurses who were on temporary disability leave or leave of absence at the time of the study.
- Questionnaires that were duplicates or had any blank questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educative InterventionThis is an educational intervention in which participants were provided with several sessions to recognize and better manage supraglottic devices. | Other | Educational intervention with pre-post intra-subject |
Primary outcome
Change from baseline level of theoretical knowledge regarding the management of DSG
Time frame: From the enrollment to the end of first objective 6 weeks
Change from baseline level of theoretical knowledge regarding the management of DSG among primary care healthcare professionals (physicians and nurses) in the Castellón Department of Health.
6 secondary outcomes
Sociodemographic characteristics
Time frame: From the enrollment to the end of the intervention, 4 weeks
Sociodemographic characteristics
Time frame: From the enrollment to the end of the intervention, 4 weeks
Sociodemographic characteristics
Time frame: From the enrollment to the end of the intervention, 4 weeks
gaps and common errors in ALS procedures
Time frame: From the enrollment to the end of the intervention 4 weeks
statistical association between sociodemographic and professional variables
Time frame: From the enrollment to the end of the intervention, 8 weeks
Comparative
Time frame: From the enrollment to the end of the intervention, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background10.1016/j.resuscitation.2021.02.007
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study is part of a doctoral thesis that will be defended in 2027.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educative Intervention in people with Enhance Patient Safety and Nurse Physician Relations, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline level of theoretical knowledge regarding the management of DSG (time frame: From the enrollment to the end of first objective 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.