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

1 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

565

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Successful Transport With Uninterrupted Respiratory Support
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Transport-Associated Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Antonio M Esquinas, Intensive Care Unit, Hospital Meseguer, Murcia, Spain
  • Cattedra di studio: Berkan Basançelebi, İstanbul Medipol University, İstanbul, Türkiye
  • Cattedra di studio: Gaspar R. Chiappa, Faculty of Health Sciences, Universidad Autónoma de Chile, Providencia, Santiago, Chile

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

31 dicembre 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

25 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 settembre 2026

Primo Inserito (Effettivo)

4 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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