Acute Respiratory FailureHERMESNCT07805603
HERMES: Quality and Safety of Advanced Respiratory Support During Patient Transport
An observational study of Acute Respiratory Failure and Respiratory Insufficiency, run by Medipol University at 4 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Respiratory Failure, Respiratory Insufficiency, Respiratory Distress
- What is being tested?
- Advanced Respiratory Support During Patient Transport
- How many people
- 565 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 31 Dec 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Colombia1 site
Advanced Respiratory Care Center
Medellín
Javier Mauricio Ramirez, advanced.respiratorycare@gmail.com
Qatar1 site
Heart Hospital, Hamad Medical Corporation
Doha
Satheesh Munusamy, +974 6617 4771, satheeshm.apk1985@gmail.com
Turkey (Türkiye)1 site
İstanbul Medipol University
Istanbul
Berkan Basançelebi, berkanbasancelebi@gmail.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Respiratory Failure, Respiratory Insufficiency, Respiratory Distress, Critical Illness, Chronic Respiratory Failure, Cardiorespiratory Failure
- Being tested
- Advanced Respiratory Support During Patient Transport
- Keywords
- Patient Transport, Intrahospital Transport, Interhospital Transport, Prehospital Transport, Noninvasive Ventilation, High-Flow Nasal Oxygen, Invasive Mechanical Ventilation, Transport Safety, Respiratory Support, Patient Safety, Critical Care Transport, Electrical Power Continuity
- Medical subject headings
- Respiratory Insufficiency, Dyspnea, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Respiratory Support During Patient TransportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Advanced Respiratory Support During Patient Transport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Transport With Uninterrupted Respiratory Support
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Secondary outcomes (9)
Transport-Associated Adverse Events
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Interruption or Unplanned Modification of Respiratory Support
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Escalation of Respiratory Support
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Requirement for an Unplanned Rescue Intervention
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Clinically Relevant Physiologic Deterioration
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.
Measured: Day 1, from the pre-transport clinical assessment immediately before departure through arrival at the intended destination
Equipment-Related Alarms and Technical Events
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Electrical Power-Related Events
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Oxygen Supply-Related Events
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Composite Transport Safety Event
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.
Measured: Day 1, during the transport episode from departure to arrival at the intended destination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start31 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 565 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- International Association of Non Invasive Ventilation, International Academy of Non Invasive Ventilation, International College of Non Invasive Ventilation
- Responsible party
- Principal investigator, Berkan Basançelebi, Medipol University
- Investigators
- Antonio M Esquinas, Study director, Intensive Care Unit, Hospital Meseguer, Murcia, SpainBerkan Basançelebi, Study chair, İstanbul Medipol University, İstanbul, TürkiyeGaspar R. Chiappa, Study chair, Faculty of Health Sciences, Universidad Autónoma de Chile, Providencia, Santiago, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805603
- Sponsor's protocol ID
- IANIV-HERMES-III
- Acronym
- HERMES
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34535244Non-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.
PubMed 30981603Hanley 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.
PubMed 6827763Veiga 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.
PubMed 30843950Parmentier-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.
PubMed 23587445Jia 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.
PubMed 26781179Schwebel 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.
PubMed 23863225Murata 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.
PubMed 34861515Fanara 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.
PubMed 20470381Warren 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.
PubMed 14707589Oczkowski 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.
PubMed 34649974Rochwerg 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.
PubMed 28860265