Airway ManagementPhEARNCT07289139
Prehospital Emergency Airway Research.
An observational study of Airway Management and Emergency, run by Centro de Emergencias Sanitarias 061 Andalucía at 1 site in Spain.
Trial summary
The creation of an airway registry will allow an improvement in the quality of care, the safety of critically ill patients in pre-hospital situations, and a reduction in morbidity and mortality related to airway management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Management, Emergency
- How many people
- 4,300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients attended by the 061 Emergency Teams of Andalusia, with an "Assistance" type of request, who underwent any of the following techniques: manual ventilation, orotracheal intubation, supraglottic device insertion, or cricothyroidotomy
Who may be able to join
- All patients attended by the 061 Emergency Teams of Andalusia, with an "Assistance" type of request, who underwent any of the following techniques: manual ventilation, orotracheal intubation, supraglottic device insertion, or cricothyroidotomy
Who cannot join
- interhospital transfers,
- patients who recieve this techniques before de emergency team arrives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PhEAR-Prehospital Emergency Airway Research.
The creation of an airway registry will allow an improvement in the quality of care, the safety of critically ill patients in pre-hospital situations, and a reduction in morbidity and mortality related to airway management.
Read the detailed description
In the care of critically ill patients in prehospital emergency settings, advanced airway management (AAM) is essential to maintain airway patency and ensure adequate oxygenation and ventilation. In Andalusia, prehospital emergency teams are composed of a physician, a nurse, and an emergency medical technician (EMT), and they operate both ground units (advanced life support ambulances) and air units (medical helicopters).
AAM encompasses a wide range of processes, techniques, and complex decision-making interventions that can be key to favorable patient outcomes. However, if not performed correctly, these procedures can also lead to adverse events, poor prognosis, or preventable mortality.
The increasing complexity and technological sophistication of healthcare require health systems to improve and adapt in order to deliver safe, high-quality care, where continuity and an integrated vision of care are essential.
This comprehensive approach is made possible through the analysis of incidents recorded in registries, which play a key role in identifying failures in clinical practice and implementing new strategies to address them.
- Conditions
- Airway Management, Emergency
- Keywords
- airway management, critical care, emergency, endotracheal intubation
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate First-pass intubation success rate
Intubations performed on the first attempt divided by the total number of intubations
Measured: 2 years
Secondary outcomes (4)
Development and validation of an artificial intelligence-based predictive algorithm for prehospital difficult airway
Measured: 2 years
Identify early and late complications in patients undergoing prehospital advanced airway management
early complications (during out-of-hospital assistance), late complications (within the first 28 days after hospital admission)
Measured: from admission until day 28 of hospitalization
calculate 28-day mortality
Number of patients with mortality within the first 28 days of hospital admission
Measured: from admission until day 28 of hospitalization
hospital length of stay
number of days of hospitalization
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jan 2025
- Primary completion12 Jul 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Emergencias Sanitarias 061 Andalucía
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina López López, Centro de Emergencias Sanitarias 061 Andalucía
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289139
- Sponsor's protocol ID
- 2025_CES_061_REG_PHEAR_V1
- Acronym
- PhEAR
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhEAR-Prehospital Emergency Airway Research.
- ClinicalTrials.gov ID
- NCT07289139
- Acronym / sponsor ID
- PhEAR / 2025_CES_061_REG_PHEAR_V1
- Conditions
- Airway Management, Emergency
- Keywords
- airway management, critical care, emergency, endotracheal intubation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,300 participants (actual)
- Lead sponsor
- Centro de Emergencias Sanitarias 061 AndalucíaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Dec 2025 (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.
The creation of an airway registry will allow an improvement in the quality of care, the safety of critically ill patients in pre-hospital situations, and a reduction in morbidity and mortality related to airway management.
Detailed description
In the care of critically ill patients in prehospital emergency settings, advanced airway management (AAM) is essential to maintain airway patency and ensure adequate oxygenation and ventilation. In Andalusia, prehospital emergency teams are composed of a physician, a nurse, and an emergency medical technician (EMT), and they operate both ground units (advanced life support ambulances) and air units (medical helicopters).
AAM encompasses a wide range of processes, techniques, and complex decision-making interventions that can be key to favorable patient outcomes. However, if not performed correctly, these procedures can also lead to adverse events, poor prognosis, or preventable mortality.
The increasing complexity and technological sophistication of healthcare require health systems to improve and adapt in order to deliver safe, high-quality care, where continuity and an integrated vision of care are essential.
This comprehensive approach is made possible through the analysis of incidents recorded in registries, which play a key role in identifying failures in clinical practice and implementing new strategies to address them.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients attended by the 061 Emergency Teams of Andalusia, with an "Assistance" type of request, who underwent any of the following techniques: manual ventilation, orotracheal intubation, supraglottic device insertion, or cricothyroidotomy
Key inclusion criteria (1 listed)
- All patients attended by the 061 Emergency Teams of Andalusia, with an "Assistance" type of request, who underwent any of the following techniques: manual ventilation, orotracheal intubation, supraglottic device insertion, or cricothyroidotomy
Key exclusion criteria (2 listed)
- interhospital transfers,
- patients who recieve this techniques before de emergency team arrives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calculate First-pass intubation success rate
Time frame: 2 years
Intubations performed on the first attempt divided by the total number of intubations
4 secondary outcomes
Development and validation of an artificial intelligence-based predictive algorithm for prehospital difficult airway
Time frame: 2 years
Identify early and late complications in patients undergoing prehospital advanced airway management
Time frame: from admission until day 28 of hospitalization
calculate 28-day mortality
Time frame: from admission until day 28 of hospitalization
hospital length of stay
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Airway Management and Emergency, run by Centro de Emergencias Sanitarias 061 Andalucía 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 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Calculate First-pass intubation success rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.