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

NCT07805603 | Not Yet Recruiting

• 1 other identifier: IANIV-HERMES-III
• Study Type: observational
• Target: 565
• Locations: 4 countries
• Sites: 4

Brief 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. 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.

Conditions

Acute Respiratory Failure; Respiratory Insufficiency; Respiratory Distress; Critical Illness; Chronic Respiratory Failure; Cardiorespiratory Failure; Mechanical Ventilation; Noninvasive Ventilation; High-Flow Nasal Oxygen Therapy; Advanced Respiratory Support; Patient Transport; Transport of Critically Ill Patients; Patient Safety During Transport; Patient Safety

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1, during the transport episode from departure to arrival at the intended destination

Secondary Outcomes (9)

• Transport-Associated Adverse Events

  Day 1, during the transport episode from departure to arrival at the intended destination

• Interruption or Unplanned Modification of Respiratory Support

  Day 1, during the transport episode from departure to arrival at the intended destination

• Escalation of Respiratory Support

  Day 1, during the transport episode from departure to arrival at the intended destination

• Requirement for an Unplanned Rescue Intervention

  Day 1, during the transport episode from departure to arrival at the intended destination

• Clinically Relevant Physiologic Deterioration

  Day 1, from the pre-transport clinical assessment immediately before departure through arrival at the intended destination

Study Arms (1)

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.

Other: Advanced Respiratory Support During Patient Transport

Interventions

Advanced Respiratory Support During Patient Transport OTHER

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.

Patients Transported During Advanced Respiratory Support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead
• International Association of Non Invasive Ventilation: collaborator
• International Academy of Non Invasive Ventilation: collaborator
• International College of Non Invasive Ventilation: collaborator

Study Sites (4)

Advanced Respiratory Care Center

Medellín, Colombia

Location

Cairo University

Cairo, Egypt

Location

Heart Hospital, Hamad Medical Corporation

Doha, Qatar

Location

İstanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 34535244 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30981603 BACKGROUND

• 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.

  PMID: 6827763 BACKGROUND

• 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.

  PMID: 30843950 BACKGROUND

• 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.

  PMID: 23587445 BACKGROUND

• 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.

  PMID: 26781179 BACKGROUND

• 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.

  PMID: 23863225 BACKGROUND

• 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.

  PMID: 34861515 BACKGROUND

• 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.

  PMID: 20470381 BACKGROUND

• 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.

  PMID: 14707589 BACKGROUND

• 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.

  PMID: 34649974 BACKGROUND

• 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.

  PMID: 28860265 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Dyspnea; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Antonio M Esquinas

  Intensive Care Unit, Hospital Meseguer, Murcia, Spain

  STUDY DIRECTOR

• Berkan Basançelebi

  İstanbul Medipol University, İstanbul, Türkiye

  STUDY CHAIR

• Gaspar R. Chiappa

  Faculty of Health Sciences, Universidad Autónoma de Chile, Providencia, Santiago, Chile

  STUDY CHAIR

Central Study Contacts

Berkan Basançelebi

CONTACT

+90 444 8 544; berkanbasancelebi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

CO (1); QA (1); TU (1); EG (1)