- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07805603
HERMES: Quality and Safety of Advanced Respiratory Support During Patient Transport (HERMES)
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.
Studieoversigt
Status
Betingelser
- Kritisk sygdom
- Respiratorisk insufficiens
- Kronisk respirationssvigt
- Akut respirationssvigt
- Mekanisk ventilation
- Non-invasiv ventilation
- Patientsikkerhed
- Åndedrætsbesvær
- Kardiorespiratorisk svigt
- High-Flow Nasal Oxygen Terapi
- Advanced Respiratory Support
- Patient Transport
- Transport of Critically Ill Patients
- Patient Safety During Transport
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Berkan Basançelebi
- Telefonnummer: +90 444 8 544
- E-mail: berkanbasancelebi@gmail.com
Studiesteder
-
-
-
Medellín, Colombia
- Advanced Respiratory Care Center
-
Kontakt:
- Javier Mauricio Ramirez
- E-mail: advanced.respiratorycare@gmail.com
-
-
-
-
-
Cairo, Egypten
- Cairo University
-
Kontakt:
- Mostafa Elshazly
- E-mail: elshazly66@hotmail.com
-
-
-
-
-
Doha, Qatar
- Heart Hospital, Hamad Medical Corporation
-
Kontakt:
- Satheesh Munusamy
- Telefonnummer: +974 6617 4771
- E-mail: satheeshm.apk1985@gmail.com
-
-
-
-
-
Istanbul, Tyrkiet (Türkiye)
- Istanbul Medipol University
-
Kontakt:
- Berkan Basançelebi
- E-mail: berkanbasancelebi@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful Transport With Uninterrupted Respiratory Support
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Transport-Associated Adverse Events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Antonio M Esquinas, Intensive Care Unit, Hospital Meseguer, Murcia, Spain
- Studiestol: Berkan Basançelebi, İstanbul Medipol University, İstanbul, Türkiye
- Studiestol: Gaspar R. Chiappa, Faculty of Health Sciences, Universidad Autónoma de Chile, Providencia, Santiago, Chile
Publikationer og nyttige links
Generelle publikationer
- Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
- Schwebel C, Clec'h C, Magne S, Minet C, Garrouste-Orgeas M, Bonadona A, Dumenil AS, Jamali S, Kallel H, Goldgran-Toledano D, Marcotte G, Azoulay E, Darmon M, Ruckly S, Souweine B, Timsit JF; OUTCOMEREA Study Group. Safety of intrahospital transport in ventilated critically ill patients: a multicenter cohort study*. Crit Care Med. 2013 Aug;41(8):1919-28. doi: 10.1097/CCM.0b013e31828a3bbd.
- Warren J, Fromm RE Jr, Orr RA, Rotello LC, Horst HM; American College of Critical Care Medicine. Guidelines for the inter- and intrahospital transport of critically ill patients. Crit Care Med. 2004 Jan;32(1):256-62. doi: 10.1097/01.CCM.0000104917.39204.0A.
- Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
- Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA. 1983 Apr 1;249(13):1743-5. No abstract available.
- Parmentier-Decrucq E, Poissy J, Favory R, Nseir S, Onimus T, Guerry MJ, Durocher A, Mathieu D. Adverse events during intrahospital transport of critically ill patients: incidence and risk factors. Ann Intensive Care. 2013 Apr 12;3(1):10. doi: 10.1186/2110-5820-3-10.
- Murata M, Nakagawa N, Kawasaki T, Yasuo S, Yoshida T, Ando K, Okamori S, Okada Y. Adverse events during intrahospital transport of critically ill patients: A systematic review and meta-analysis. Am J Emerg Med. 2022 Feb;52:13-19. doi: 10.1016/j.ajem.2021.11.021. Epub 2021 Nov 20.
- Jeyaraju M, Andhavarapu S, Palmer J, Bzhilyanskaya V, Friedman E, Lurie T, Patel P, Raffman A, Wang J, Tran QK. Safety Matters: A Meta-analysis of Interhospital Transport Adverse Events in Critically Ill Patients. Air Med J. 2021 Sep-Oct;40(5):350-358. doi: 10.1016/j.amj.2021.04.008. Epub 2021 May 24.
- Non-Invasive Ventilation Transport: Insights from International Practice and New Technology. Eur Respir J. 2025;66(Suppl 69):PA2071. doi:10.1183/13993003.congress-2025.PA2071
- Williams P, Karuppiah S, Greentree K, Darvall J. A checklist for intrahospital transport of critically ill patients improves compliance with transportation safety guidelines. Aust Crit Care. 2020 Jan;33(1):20-24. doi: 10.1016/j.aucc.2019.02.004. Epub 2019 Apr 10.
- Veiga VC, Postalli NF, Alvarisa TK, Travassos PP, Vale RTDS, Oliveira CZ, Rojas SSO. Adverse events during intrahospital transport of critically ill patients in a large hospital. Rev Bras Ter Intensiva. 2019;31(1):15-20. doi: 10.5935/0103-507X.20190003. Epub 2019 Feb 28.
- Jia L, Wang H, Gao Y, Liu H, Yu K. High incidence of adverse events during intra-hospital transport of critically ill patients and new related risk factors: a prospective, multicenter study in China. Crit Care. 2016 Jan 18;20:12. doi: 10.1186/s13054-016-1183-y.
- Fanara B, Manzon C, Barbot O, Desmettre T, Capellier G. Recommendations for the intra-hospital transport of critically ill patients. Crit Care. 2010;14(3):R87. doi: 10.1186/cc9018. Epub 2010 May 14.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IANIV-HERMES-III
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .