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HERMES: International Survey and Portable External Power Evaluation During Respiratory Support Transport (HERMES)

4 września 2026 zaktualizowane przez: Berkan Basançelebi, Medipol University

Prehospital Transport During Advanced Respiratory Support: An International Survey and Prospective Feasibility Evaluation of Portable External Power

The HERMES Phase I-II study was a two-phase observational investigation designed to characterize contemporary practices and safety-related challenges associated with the transport of patients requiring advanced respiratory support and to assess the operational feasibility of portable external electrical power during ambulance transport.

Phase I consisted of an international electronic cross-sectional survey of healthcare professionals involved in noninvasive ventilation (NIV) management or patient transport. The survey evaluated reported transport indications, ventilator type and positioning, respiratory interfaces, transport-team composition, and perceived patient-, equipment-, and environment-related problems.

Phase II was a prospective descriptive feasibility evaluation involving 25 ambulance transports performed in Albacete and Bilbao, Spain. Patients were transported while receiving high-flow nasal oxygen (HFNO), rescue NIV, or invasive mechanical ventilation. A portable external power supply was used to support continuity of powered respiratory-support equipment during transport. The primary technical feasibility outcome was successful completion of transport while maintaining respiratory support without reported power interruption, clinically relevant equipment alarm, or technical failure.

The two phases were analyzed independently and were intended to characterize respiratory-support transport practices and evaluate technical and operational feasibility rather than establish comparative effectiveness, clinical superiority, or prevention of clinical deterioration.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Patients receiving advanced respiratory support may require prehospital, interhospital, or intrahospital transport for diagnostic procedures, therapeutic interventions, transfer to a higher level of care, or continuation of acute management. Noninvasive ventilation and high-flow nasal oxygen are established forms of respiratory support in acute respiratory failure, while invasive mechanical ventilation remains necessary in patients with more severe or refractory respiratory failure. During transport, continuity of respiratory support must be maintained despite changes in environment, personnel, equipment configuration, oxygen availability, and electrical power supply.

Transport of critically ill patients represents a recognized period of increased clinical and technical vulnerability. International recommendations emphasize adequate stabilization before transport, appropriate physiologic monitoring, trained accompanying personnel, communication between clinical teams, verification of equipment function, sufficient oxygen and power reserves, and contingency planning for foreseeable clinical deterioration or device failure. Prospective cohort studies and systematic reviews have demonstrated that transport-associated adverse events may include physiologic deterioration, equipment malfunction, circuit or airway problems, interruptions in therapy, and organizational or communication failures. The reported frequency of such events varies substantially according to patient population, transport setting, event definitions, urgency, and surveillance methodology.

Against this background, the HERMES Phase I-II program was developed as two analytically distinct observational phases.

Phase I was an international electronic cross-sectional survey targeting healthcare professionals involved in NIV management or patient transport. The objective was to characterize reported clinical and organizational practices related to the transport of patients requiring noninvasive respiratory support and to identify perceived areas of vulnerability during transport.

The available survey records were timestamped from February 20 to May 6, 2023. The dataset contained 224 response records. Survey domains included indications for transport, type and positioning of ventilators, use of respiratory interfaces, composition of the transport team, and categories of patient-, equipment-, and environment-related problems.

The respondent record was the unit of analysis. Reported problems reflected respondents' perceptions or previous clinical experience and were therefore not interpreted as prospectively adjudicated adverse-event incidence. Because the available documentation did not establish the invitation denominator, recruitment channels, participating countries and institutions, reminder procedures, or a prespecified definition of questionnaire completion, a formal response rate and country- or institution-level prevalence estimates were not calculated.

The rationale for this phase was based on the recognized variability in transport organization and on the importance of standardized preparation, appropriately trained personnel, continuous monitoring, equipment checks, adequate resource planning, and predefined safety procedures. Structured transport protocols and checklists may further improve adherence to transport-safety recommendations and promote more consistent preparation before patient transfer.

Phase II was designed as a prospective descriptive feasibility evaluation of portable external electrical power during ambulance transport of patients requiring advanced respiratory support. Twenty-five transport episodes were prospectively recorded at participating units in Albacete and Bilbao, Spain. The cohort included 24 adults and one child.

Respiratory-support modalities included HFNO, rescue NIV, and invasive mechanical ventilation during cardiopulmonary resuscitation. A Zopec Transport UPS 90 external power supply was used during transport to support continuity of powered respiratory-support equipment. Respiratory-support devices, oxygen delivery, monitoring, and other aspects of clinical management remained determined by the treating clinical teams according to local practice.

The primary technical feasibility outcome was completion of ambulance transport while maintaining prescribed respiratory support without reported electrical power interruption, clinically relevant equipment alarm, or technical failure requiring corrective intervention. Additional descriptive variables included respiratory-support modality, transport duration, rescue respiratory support, technical events, operational complexity, and changes in respiratory support.

Electrical continuity represents an important component of transport safety because contemporary respiratory-support systems may depend simultaneou

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

246

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Jeddah, Arabia Saudyjska
        • Department of Respiratory Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University
      • Punta Arenas, Chile
        • Intensive care Unit, Hospital General Ramos Mejia, Buenos Aires Argentina School of Medicine, University of Magallanes
      • Santiago, Chile
        • Faculty of Health Sciences, Universidad Autónoma de Chile
      • Zagreb, Chorwacja
        • Department of Anaesthesiology and ICU, University Hospital Centre Zagreb
      • Cairo, Egipt
        • Chest Department, Cairo University Hospitals
      • Albacete, Hiszpania
        • Mobile Emergency Unit of Albacete, Department of Urgent Care, Emergencies and Medical Transport of Castilla-La Mancha
      • Algeciras, Hiszpania
        • Intensive Care Unit, Hospital Punta de Europa
      • Bilbao, Hiszpania
        • Emergentziak, Osakidetza
      • Murcia, Hiszpania
        • Intensive Care Unit. Hospital Morales Meseguer
      • Mangalore, Indie
        • Department of Respiratory Medicine, Father Muller Medical College Hospital
      • Tehran, Iran
        • Shahid Beheshti University of Medical Sciences
      • Sanaa, Jemen
        • Al-Razi University
      • Sanaa, Jemen
        • Department of Respiratory Therapy, Ibn- al-Nafis University for Medical Sciences
      • Doha, Katar
        • Heart Hospital, HMC
      • Mexico City, Meksyk
        • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Servicio de Neumología
      • Sohar, Oman
        • Department of Medicine, College of Medicine and Health Sciences, National University of Science and Technology
    • New York
      • Mount Kisco, New York, Stany Zjednoczone, 10549
        • Department Pulmonary Critical Care and Sleep Medicine Northwell Northern Westchester Hospital
      • Hatay, Turcja (Türkiye)
        • Department of Pulmonology, Tayfur Ata Sökmen Faculty of Medicine, Hatay Mustafa Kemal University
      • Istanbul, Turcja (Türkiye)
        • Istanbul Medipol University
      • Naples, Włochy
        • Department of Critical Care, UOC Anesthesia, Postoperative Intensive Care and ECMO, Monaldi Hospital, AORN Ospedali dei Colli

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

The study population comprised two distinct groups. Phase I included healthcare professionals involved in noninvasive ventilation management or patient transport who participated in an international electronic cross-sectional survey addressing respiratory-support transport practices. Phase II included patients undergoing ambulance transport while receiving advanced respiratory support, including high-flow nasal oxygen, noninvasive ventilation, or invasive mechanical ventilation, in participating units in Albacete and Bilbao, Spain. The two populations were analyzed separately and were not statistically combined.

Opis

Phase I - International Healthcare Professional Survey

Inclusion Criteria:

  • Healthcare professionals involved in the management of noninvasive ventilation or in the transport of patients requiring respiratory support.
  • Participation in the international electronic survey addressing respiratory-support transport practices.

Exclusion Criteria:

  • Records not representing participation in the respiratory-support transport survey.
  • Records lacking sufficient information for descriptive analysis of the predefined survey domains.

Phase II - Portable External Power Feasibility Evaluation

Inclusion Criteria:

  • Patients undergoing ambulance transport while receiving advanced respiratory support.
  • Receipt of high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or invasive mechanical ventilation during the transport episode.
  • Transport performed at one of the participating clinical units included in the prospective feasibility evaluation.
  • Availability of transport-level data sufficient to evaluate continuity of respiratory support and the occurrence of power interruption, clinically relevant equipment alarm, or technical failure.

Exclusion Criteria:

  • Transport episodes not involving advanced respiratory support.
  • Transport episodes for which continuity of respiratory support or the primary technical feasibility outcome could not be determined.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Phase I - International Healthcare Professional Survey
Healthcare professionals involved in noninvasive ventilation management or patient transport who participated in the international electronic cross-sectional survey. The survey assessed reported transport indications, ventilator type and positioning, respiratory-interface use, transport-team composition, and perceived patient-, equipment-, and environment-related problems. The survey dataset contained 224 response records corresponding to 221 unique respondents.
Phase II - Portable External Power Feasibility Cohort
Patients undergoing ambulance transport while receiving advanced respiratory support, including high-flow nasal oxygen, rescue noninvasive ventilation, or invasive mechanical ventilation. Portable external electrical power was prospectively evaluated for continuity of powered respiratory-support equipment during transport. Clinical management and respiratory-support decisions were determined according to routine clinical practice.
A Zopec Transport UPS 90 portable external power supply was used during ambulance transport to provide continuous electrical power to powered respiratory-support equipment. The feasibility evaluation assessed maintenance of respiratory support during transport and the occurrence of power interruption, clinically relevant equipment alarms, or technical failure.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number and Percentage of Respondents Reporting Predefined Respiratory-Support Transport Practices
Ramy czasowe: Baseline
Number and percentage of Phase I survey respondents reporting predefined respiratory-support transport practices, including transport indications, ventilator type and positioning, respiratory-interface use, and transport-team composition.
Baseline
Number and Percentage of Ambulance Transports Completed With Uninterrupted Respiratory Support
Ramy czasowe: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Number and percentage of Phase II ambulance transport episodes completed with uninterrupted respiratory support and without reported electrical power interruption, clinically relevant equipment alarm, or technical failure. This outcome represented the primary technical feasibility measure of the portable external power evaluation.
From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number and Percentage of Respondents Reporting Transport-Related Problems
Ramy czasowe: Baseline
Number and percentage of Phase I survey respondents reporting patient-related, equipment-related, or environmental problems associated with respiratory-support transport. These responses reflected participants' reported perceptions or previous experience and did not represent prospectively adjudicated adverse-event incidence.
Baseline
Number and Percentage of Respondents Reporting Each Transport-Team Professional Category
Ramy czasowe: Baseline
Number and percentage of Phase I survey respondents reporting the involvement of physicians, nurses, respiratory therapists, nursing assistants, or other healthcare personnel during respiratory-support transport. Multiple selections were permitted.
Baseline
Number and Percentage of Ambulance Transports by Respiratory-Support Modality
Ramy czasowe: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Number and percentage of Phase II ambulance transport episodes involving high-flow nasal oxygen (HFNO), rescue noninvasive ventilation (NIV), or invasive mechanical ventilation.
From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Number and Percentage of Patients Requiring Escalation or Modification of Respiratory Support
Ramy czasowe: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Number and percentage of Phase II patients requiring escalation or clinically indicated modification of respiratory support during ambulance transport, including transition to rescue noninvasive ventilation or invasive mechanical ventilation.
From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Number and Percentage of Ambulance Transports With Power Interruption, Clinically Relevant Equipment Alarm, or Technical Failure
Ramy czasowe: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Number and percentage of Phase II ambulance transport episodes in which at least one electrical power interruption, clinically relevant equipment alarm, or technical failure was reported during use of the portable external power system.
From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Ambulance Transport Duration in Minutes
Ramy czasowe: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Duration of each Phase II ambulance transport episode, measured in minutes from departure from the point of origin to arrival at the intended destination. Transport duration was summarized using mean and standard deviation, median and interquartile range, and observed range.
From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Dyrektor Studium: Antonio Esquinas, Intensive Care Unit, Hospital Meseguer, Murcia, Spain
  • Krzesło do nauki: Berkan Basançelebi, Medipol University
  • Krzesło do nauki: Satheesh Munusamy, Heart Hospital, HMC, Qatar

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 lutego 2023

Zakończenie podstawowe (Rzeczywisty)

20 maja 2023

Ukończenie studiów (Rzeczywisty)

20 lutego 2025

Daty rejestracji na studia

Pierwszy przesłany

25 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 września 2026

Pierwszy wysłany (Rzeczywisty)

8 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • IANIV-HERMES-I-II

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Deidentified individual participant data underlying the reported study results may be made available to qualified researchers upon reasonable request. Data sharing will be considered only for scientifically justified proposals and will be subject to approval by the HERMES Steering Committee, applicable ethics requirements, institutional policies, participant consent provisions, and relevant data-protection regulations. Data elements that could increase the risk of participant re-identification or that cannot be shared under applicable ethical, legal, or institutional requirements will not be provided. A data-use agreement may be required before access is granted.

Ramy czasowe udostępniania IPD

Deidentified individual participant data and available supporting information may be made available beginning 6 months after publication of the primary study results and for up to 5 years thereafter.

Kryteria dostępu do udostępniania IPD

Deidentified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request. Requests must include a scientifically justified and methodologically appropriate research proposal and will be reviewed by the HERMES Steering Committee. Access will be limited to data necessary for the approved analysis and will remain subject to applicable ethics approvals, participant consent provisions, institutional policies, and data-protection regulations. Variables that cannot be adequately deidentified or are restricted by ethical, legal, or institutional requirements will not be shared. A data-use agreement may be required before access is granted.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .