Pre-hospital identification of prognostic biomarkers in time-dependent diseases

Predictive value of biological, physiological and analytical biomarkers in the prehospital scope: observational, prospective, analytical, non-intervention and multicenter study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN48326533

Enrollment

900

Registered

2019-11-04

Start date

2019-12-01

Completion date

Unknown

Last updated

2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early mortality in all types of patients without evident signs of severity Other

Interventions

Patients and/or participants undergo a structured and objective evaluation according to protocol and proceed to its stabilization. The physiological variables are collected (respiratory rate, saturati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Treated by an ALSU 2. Aged over 18 years 3. Provide informed consent

Exclusion criteria

Exclusion criteria: 1. Aged under 18 years 2. Cardiorespiratory arrest or exitus prior to arrival at the hospital 3. Pregnant 4. Psychiatric pathology 5. Diagnosis of end-stage disease (in treatment at a palliative care unit) 6. ALSU takes longer than 45 minutes to arrive 7. Evacuated by transport other than ambulance 8. Do not require transfer to the hospital

Design outcomes

Primary

Measure	Time frame
The following are evaluated at first attention at the scene of the incident: 1. Respiratory frequency, assessed using clinical observation at baseline 2. Oxygen saturation, assessed using a Physio LifePAK® 15 monitor at baseline 3. Non invasive ETCO2, assessed using a Physio LifePAK® 15 monitor at baseline 4. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline 5. Blood pressure, assessed using a Physio LifePAK® 15 monitor at baseline 6. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000 at baseline 7. Patient consciousness, assessed using the Glasgow Coma Scale at baseline 8. Use of oxygen (or not), evaluated using clinical observation at baseline 9. Analytical biomarkers: pH, pCO2, pO2, cHCO3-, BE (ecf), cSO2, Na +, K +, Ca ++, Cl-, TCO2, Agap, AGapK, Hct, Hb, BE (b), Glu, Lac, BUN, Urea and Crea, assessed using EPOC Siemens Healthcare at baseline 10. Electrocardiogram assessed using a Physio LifePAK® 15 monitor at baseline 11. Initial and route FiO2 assessed using a Physio LifePAK® 15 monitor at baseline 12. Prehospital diagnosis according to the Medical Priority Dispatch System incident code at baseline	—

Measure

Time frame

The following are evaluated at first attention at the scene of the incident: 1. Respiratory frequency, assessed using clinical observation at baseline 2. Oxygen saturation, assessed using a Physio LifePAK® 15 monitor at baseline 3. Non invasive ETCO2, assessed using a Physio LifePAK® 15 monitor at baseline 4. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline 5. Blood pressure, assessed using a Physio LifePAK® 15 monitor at baseline 6. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000 at baseline 7. Patient consciousness, assessed using the Glasgow Coma Scale at baseline 8. Use of oxygen (or not), evaluated using clinical observation at baseline 9. Analytical biomarkers: pH, pCO2, pO2, cHCO3-, BE (ecf), cSO2, Na +, K +, Ca ++, Cl-, TCO2, Agap, AGapK, Hct, Hb, BE (b), Glu, Lac, BUN, Urea and Crea, assessed using EPOC Siemens Healthcare at baseline 10. Electrocardiogram assessed using a Physio LifePAK® 15 monitor at baseline 11. Initial and route FiO2 assessed using a Physio LifePAK® 15 monitor at baseline 12. Prehospital diagnosis according to the Medical Priority Dispatch System incident code at baseline

—

Secondary

Measure	Time frame
1. Early mortality at 48 hours 2. Presence of serious adverse events in prehospital scope at baseline 3. Presence of serious adverse events in hospital at 48 hours 4. Need for Intensive Care Unit at 30 days 5. Mortality from any cause at 30 days	—

Countries

Spain

Contacts

Public ContactFrancisco Martín-Rodríguez

fmartin@phet.es+34 (0)686452313

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026