- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289139
Prehospital Emergency Airway Research. (PhEAR)
PhEAR-Prehospital Emergency Airway Research.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Málaga, Spain, 29590
- Centro de Emergencias Sanitarias 061 Andalucía
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- interhospital transfers,
- patients who recieve this techniques before de emergency team arrives
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calculate First-pass intubation success rate
Time Frame: 2 years
|
Intubations performed on the first attempt divided by the total number of intubations
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development and validation of an artificial intelligence-based predictive algorithm for prehospital difficult airway
Time Frame: 2 years
|
2 years
|
|
|
Identify early and late complications in patients undergoing prehospital advanced airway management
Time Frame: from admission until day 28 of hospitalization
|
early complications (during out-of-hospital assistance), late complications (within the first 28 days after hospital admission)
|
from admission until day 28 of hospitalization
|
|
calculate 28-day mortality
Time Frame: from admission until day 28 of hospitalization
|
Number of patients with mortality within the first 28 days of hospital admission
|
from admission until day 28 of hospitalization
|
|
hospital length of stay
Time Frame: one year
|
number of days of hospitalization
|
one year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025_CES_061_REG_PHEAR_V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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