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HERMES: Quality and Safety of Advanced Respiratory Support During Patient Transport (HERMES)

1. září 2026 aktualizováno: Berkan Basançelebi, Medipol University

The HERMES Program: An International Multicenter Prospective Study of Quality and Safety During Transport of Patients Receiving Advanced Respiratory Support

The HERMES Phase III study is an international, multicenter, prospective observational investigation designed to characterize the quality and safety of patient transport during advanced respiratory support.

The study will enroll patients undergoing prehospital, interhospital, or intrahospital transport while receiving advanced respiratory support, including high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or invasive mechanical ventilation, as determined by routine clinical practice. The study protocol will not assign respiratory-support modalities, transport strategies, or therapeutic interventions.

The primary objective is to prospectively evaluate clinical, technical, organizational, and transport-related factors associated with the safe continuation of respiratory support throughout patient transport. Data collection will include patient characteristics, respiratory-support modality and settings, transport characteristics, physiologic monitoring, transport-team composition, oxygen and electrical power resources, equipment-related events, interruptions or modifications of respiratory support, clinical deterioration, rescue interventions, escalation of respiratory support, and other transport-associated adverse events.

HERMES Phase III constitutes the prospective multicenter component of a broader research program that previously included an international survey of respiratory-support transport practices and an exploratory prospective feasibility evaluation of portable external power during ambulance transport.

Přehled studie

Detailní popis

The transport of patients requiring advanced respiratory support represents a potentially vulnerable period in the continuum of acute and critical care. During transport, the continuity of ventilation or oxygen therapy, physiologic monitoring, oxygen availability, electrical power supply, equipment functionality, appropriately trained personnel, communication, and contingency planning must be maintained despite the logistical and environmental constraints associated with patient transfer.

Earlier phases of the HERMES research program identified substantial heterogeneity in reported respiratory-support transport practices, including variations in transport indications, ventilator type and positioning, respiratory interfaces, team composition, and patient-, equipment-, and environment-related problems. A subsequent prospective feasibility phase evaluated the use of portable external electrical power during ambulance transport and provided preliminary evidence regarding the operational feasibility of maintaining continuous respiratory support and electrical power during transport. These initial phases were exploratory and were not designed to determine comparative effectiveness, establish device superiority, or provide robust estimates of the incidence or predictors of transport-related adverse events.

HERMES Phase III has therefore been designed as an international, multicenter, prospective observational study to provide a systematic evaluation of contemporary transport practices and to characterize the clinical and technical safety of transporting patients who require advanced respiratory support.

Eligible transport episodes will be prospectively recorded at participating centers. All clinical decisions will remain under the responsibility of the treating healthcare team and will be undertaken in accordance with local protocols and routine clinical practice. Participation in the study will not determine the indication for transport, respiratory-support modality, ventilator or oxygen-delivery device, electrical power source, transport equipment, monitoring strategy, staffing configuration, escalation of respiratory support, or any other therapeutic intervention.

Data will be prospectively collected across predefined clinical, technical, organizational, and operational domains. Variables will include patient demographic and clinical characteristics; indication, origin, destination, and setting of transport; respiratory-support modality and relevant device settings; transport duration; physiologic monitoring; composition and professional background of the accompanying transport team; oxygen availability and consumption, where available; electrical power resources; equipment configuration; alarms and technical events; interruption, modification, or loss of respiratory support; rescue interventions; escalation of respiratory support; and clinically relevant physiologic deterioration occurring during transport.

Particular emphasis will be placed on the continuity of prescribed respiratory support and on the prospective identification of patient-related, equipment-related, technical, organizational, and environmental events. Transport-associated adverse events and rescue interventions will be documented, where available, together with their timing, severity, clinical consequences, and the corrective measures undertaken by the transport team.

The study will further explore associations between transport-related outcomes and potentially relevant factors, including patient characteristics, respiratory-support modality, transport duration and setting, staffing configuration, monitoring strategy, equipment characteristics, oxygen availability, electrical power limitations, and other operational variables. These analyses are intended to identify factors that may be associated with an increased risk of transport-related complications, interruption of respiratory support, or the need for rescue intervention.

As an observational study, HERMES Phase III will not mandate any experimental intervention or modification of routine clinical care. Its objectives are to describe contemporary international practice, quantify clinically and technically relevant transport-associated events, identify potentially modifiable factors related to transport quality and safety, and generate evidence that may inform the development of future standardized approaches to the safe transport of patients receiving advanced respiratory support.

Typ studie

Pozorovací

Zápis (Odhadovaný)

565

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Patients of any age undergoing clinically indicated prehospital, interhospital, or intrahospital transport while receiving advanced respiratory support will be eligible for inclusion. Advanced respiratory support will include high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), including continuous or bilevel positive airway pressure, and invasive mechanical ventilation. Participants will be enrolled prospectively at participating international centers during routine clinical care. The indication for transport, respiratory-support modality, monitoring strategy, transport equipment, oxygen and electrical power sources, staffing configuration, and all therapeutic decisions will be determined by the treating clinical team according to local clinical practice and will not be assigned by the study protocol. The study population is intended to reflect real-world patients requiring advanced respiratory support during transport across emergency, critical care, and hospital settings.

Popis

Inclusion Criteria:

  • Patients undergoing a clinically indicated prehospital, interhospital, or intrahospital transport.
  • Patients receiving advanced respiratory support at the beginning of the transport episode, including at least one of the following:

High-flow nasal oxygen (HFNO); Noninvasive ventilation (NIV), including continuous positive airway pressure or bilevel positive airway pressure; Invasive mechanical ventilation.

  • Respiratory support and transport management determined by the treating clinical team according to routine clinical practice and local institutional protocols.
  • Availability of the minimum data required to document the transport episode, including respiratory-support modality and transport outcome.
  • Provision of informed consent by the patient or legally authorized representative when required by the applicable local ethics committee and national regulations, or inclusion under an approved waiver or alternative consent procedure where applicable.

Exclusion Criteria:

  • Transport performed without HFNO, NIV, or invasive mechanical ventilation.
  • Transport in which respiratory-support modality or another therapeutic intervention is assigned specifically by the HERMES study protocol rather than by routine clinical care.
  • Transport episodes for which the minimum dataset required to determine the primary outcome cannot be obtained.
  • Withdrawal of consent when consent is required and withdrawal occurs before the participant's data can be included according to applicable regulations.
  • Transport episodes entered in error or duplicate records referring to the same transport event.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Patients Transported During Advanced Respiratory Support
Patients undergoing prehospital, interhospital, or intrahospital transport while receiving advanced respiratory support, including high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or invasive mechanical ventilation, according to routine clinical practice. Respiratory-support modality, monitoring, transport equipment, oxygen and electrical power resources, staffing, and all therapeutic decisions will be determined by the treating clinical team and will not be assigned by the study protocol. Clinical, physiologic, technical, organizational, and transport-related variables will be prospectively recorded throughout the transport episode.
Exposure to advanced respiratory support during prehospital, interhospital, or intrahospital transport, including high-flow nasal oxygen, noninvasive ventilation, or invasive mechanical ventilation, as determined by routine clinical practice. No respiratory-support modality is assigned by the study protocol.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Successful Transport With Uninterrupted Respiratory Support
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes completed while maintaining the prescribed respiratory-support strategy without unplanned interruption attributable to electrical power failure, clinically relevant equipment alarm, or technical malfunction requiring corrective intervention. A transport episode will be classified as successful when the intended respiratory support is maintained from departure to arrival without a power- or equipment-related interruption that compromises delivery of respiratory support.
Day 1, during the transport episode from departure to arrival at the intended destination

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Transport-Associated Adverse Events
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which at least one clinically relevant transport-associated adverse event occurs. Events will be prospectively documented and classified according to predefined study criteria as patient-related, respiratory-support-related, equipment-related, technical, organizational, or environmental events.
Day 1, during the transport episode from departure to arrival at the intended destination
Interruption or Unplanned Modification of Respiratory Support
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes requiring an unplanned temporary interruption, modification, replacement, or discontinuation of the respiratory-support strategy being delivered at departure. The type of event, reason for the modification, duration of interruption where measurable, and corrective action undertaken will be recorded.
Day 1, during the transport episode from departure to arrival at the intended destination
Escalation of Respiratory Support
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of patients requiring escalation to a higher level of respiratory support during transport because of clinical deterioration or inadequate respiratory support. Escalation may include transition from high-flow nasal oxygen to noninvasive ventilation or from noninvasive respiratory support to invasive mechanical ventilation. Other clinically relevant escalation pathways will be recorded according to the respiratory-support modality present at departure.
Day 1, during the transport episode from departure to arrival at the intended destination
Requirement for an Unplanned Rescue Intervention
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes requiring at least one unplanned rescue intervention in response to clinical deterioration, respiratory-support failure, equipment malfunction, oxygen limitation, electrical power limitation, airway-related problems, or another transport-associated event. Rescue interventions may include manual ventilation, emergency airway management, respiratory-interface adjustment or replacement, device replacement, change in respiratory-support modality, or another immediate corrective intervention.
Day 1, during the transport episode from departure to arrival at the intended destination
Clinically Relevant Physiologic Deterioration
Časové okno: Day 1, from the pre-transport clinical assessment immediately before departure through arrival at the intended destination
Number and proportion of patients experiencing clinically relevant deterioration in one or more routinely monitored physiologic variables during transport. Variables may include oxygen saturation, respiratory rate, heart rate, blood pressure, level of consciousness, and other clinically available parameters. Clinically relevant deterioration will be defined prospectively according to prespecified thresholds and/or the requirement for corrective clinical intervention.
Day 1, from the pre-transport clinical assessment immediately before departure through arrival at the intended destination
Equipment-Related Alarms and Technical Events
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which a clinically relevant alarm or technical event involving respiratory-support, oxygen-delivery, monitoring, or transport equipment occurs. Events will include device malfunction, circuit or interface problems, accidental disconnection, equipment instability, clinically relevant alarms requiring intervention, or device replacement. Events resulting in interruption or modification of respiratory support will be identified separately.
Day 1, during the transport episode from departure to arrival at the intended destination
Electrical Power-Related Events
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which an electrical power-related event occurs, including unexpected battery depletion, insufficient remaining battery capacity, failure or loss of an intended power source, requirement for an unplanned change of power source, power-related device alarm requiring intervention, or interruption of respiratory-support equipment attributable to inadequate electrical power availability.
Day 1, during the transport episode from departure to arrival at the intended destination
Oxygen Supply-Related Events
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which an oxygen supply-related event occurs, including unexpected depletion or insufficiency of the planned oxygen reserve, requirement for an unplanned change of oxygen source, inability to provide the prescribed oxygen flow or concentration, or modification or interruption of respiratory support attributable to oxygen-supply limitations.
Day 1, during the transport episode from departure to arrival at the intended destination
Composite Transport Safety Event
Časové okno: Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which at least one predefined clinically or technically relevant safety event occurs. The composite will include interruption or unplanned modification of prescribed respiratory support, clinically relevant physiologic deterioration, escalation of respiratory support, unplanned rescue intervention, equipment-related technical failure, electrical power-related event, or oxygen supply-related event. Individual components of the composite will also be reported separately.
Day 1, during the transport episode from departure to arrival at the intended destination

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Ředitel studie: Antonio M Esquinas, Intensive Care Unit, Hospital Meseguer, Murcia, Spain
  • Studijní židle: Berkan Basançelebi, İstanbul Medipol University, İstanbul, Türkiye
  • Studijní židle: Gaspar R. Chiappa, Faculty of Health Sciences, Universidad Autónoma de Chile, Providencia, Santiago, Chile

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

31. prosince 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

25. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

1. září 2026

První zveřejněno (Aktuální)

4. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Deidentified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the HERMES study steering committee and will require submission of a scientifically justified proposal and, where appropriate, execution of a data-use agreement. Data sharing will be subject to applicable ethical approvals, institutional policies, and national and international data-protection regulations.

Časový rámec sdílení IPD

Deidentified individual participant data and the specified supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

Kritéria přístupu pro sdílení IPD

Deidentified IPD and supporting information will be available to qualified researchers who submit a scientifically justified and methodologically sound research proposal. Requests will be reviewed by the HERMES Steering Committee. Access will be granted only for approved research purposes and may require execution of a data-use agreement. Shared data will be limited to the variables necessary for the approved analysis and will be provided in a secure, deidentified format in accordance with applicable ethics approvals, institutional policies, and data-protection regulations.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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