NCT07807189

Brief Summary

The HERMES Phase I-II study was a two-phase observational investigation designed to characterize contemporary practices and safety-related challenges associated with the transport of patients requiring advanced respiratory support and to assess the operational feasibility of portable external electrical power during ambulance transport. Phase I consisted of an international electronic cross-sectional survey of healthcare professionals involved in noninvasive ventilation (NIV) management or patient transport. The survey evaluated reported transport indications, ventilator type and positioning, respiratory interfaces, transport-team composition, and perceived patient-, equipment-, and environment-related problems. Phase II was a prospective descriptive feasibility evaluation involving 25 ambulance transports performed in Albacete and Bilbao, Spain. Patients were transported while receiving high-flow nasal oxygen (HFNO), rescue NIV, or invasive mechanical ventilation. A portable external power supply was used to support continuity of powered respiratory-support equipment during transport. The primary technical feasibility outcome was successful completion of transport while maintaining respiratory support without reported power interruption, clinically relevant equipment alarm, or technical failure. The two phases were analyzed independently and were intended to characterize respiratory-support transport practices and evaluate technical and operational feasibility rather than establish comparative effectiveness, clinical superiority, or prevention of clinical deterioration.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
14 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

August 25, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

Patient TransportIntrahospital TransportInterhospital TransportPrehospital TransportNoninvasive VentilationHigh-Flow Nasal OxygenMechanical VentilationAdvanced Respiratory SupportTransport SafetyPatient SafetyPortable External PowerElectrical Power ContinuityCritical Care TransportRespiratory SupportEquipment-Related Events

Outcome Measures

Primary Outcomes (2)

  • Number and Percentage of Respondents Reporting Predefined Respiratory-Support Transport Practices

    Number and percentage of Phase I survey respondents reporting predefined respiratory-support transport practices, including transport indications, ventilator type and positioning, respiratory-interface use, and transport-team composition.

    Baseline

  • Number and Percentage of Ambulance Transports Completed With Uninterrupted Respiratory Support

    Number and percentage of Phase II ambulance transport episodes completed with uninterrupted respiratory support and without reported electrical power interruption, clinically relevant equipment alarm, or technical failure. This outcome represented the primary technical feasibility measure of the portable external power evaluation.

    From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)

Secondary Outcomes (6)

  • Number and Percentage of Respondents Reporting Transport-Related Problems

    Baseline

  • Number and Percentage of Respondents Reporting Each Transport-Team Professional Category

    Baseline

  • Number and Percentage of Ambulance Transports by Respiratory-Support Modality

    From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)

  • Number and Percentage of Patients Requiring Escalation or Modification of Respiratory Support

    From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)

  • Number and Percentage of Ambulance Transports With Power Interruption, Clinically Relevant Equipment Alarm, or Technical Failure

    From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)

  • +1 more secondary outcomes

Study Arms (2)

Phase I - International Healthcare Professional Survey

Healthcare professionals involved in noninvasive ventilation management or patient transport who participated in the international electronic cross-sectional survey. The survey assessed reported transport indications, ventilator type and positioning, respiratory-interface use, transport-team composition, and perceived patient-, equipment-, and environment-related problems. The survey dataset contained 224 response records corresponding to 221 unique respondents.

Phase II - Portable External Power Feasibility Cohort

Patients undergoing ambulance transport while receiving advanced respiratory support, including high-flow nasal oxygen, rescue noninvasive ventilation, or invasive mechanical ventilation. Portable external electrical power was prospectively evaluated for continuity of powered respiratory-support equipment during transport. Clinical management and respiratory-support decisions were determined according to routine clinical practice.

Device: Portable External Power Supply

Interventions

A Zopec Transport UPS 90 portable external power supply was used during ambulance transport to provide continuous electrical power to powered respiratory-support equipment. The feasibility evaluation assessed maintenance of respiratory support during transport and the occurrence of power interruption, clinically relevant equipment alarms, or technical failure.

Phase II - Portable External Power Feasibility Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population comprised two distinct groups. Phase I included healthcare professionals involved in noninvasive ventilation management or patient transport who participated in an international electronic cross-sectional survey addressing respiratory-support transport practices. Phase II included patients undergoing ambulance transport while receiving advanced respiratory support, including high-flow nasal oxygen, noninvasive ventilation, or invasive mechanical ventilation, in participating units in Albacete and Bilbao, Spain. The two populations were analyzed separately and were not statistically combined.

You may qualify if:

  • Healthcare professionals involved in the management of noninvasive ventilation or in the transport of patients requiring respiratory support.
  • Participation in the international electronic survey addressing respiratory-support transport practices.

You may not qualify if:

  • Records not representing participation in the respiratory-support transport survey.
  • Records lacking sufficient information for descriptive analysis of the predefined survey domains.
  • Phase II - Portable External Power Feasibility Evaluation
  • Patients undergoing ambulance transport while receiving advanced respiratory support.
  • Receipt of high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or invasive mechanical ventilation during the transport episode.
  • Transport performed at one of the participating clinical units included in the prospective feasibility evaluation.
  • Availability of transport-level data sufficient to evaluate continuity of respiratory support and the occurrence of power interruption, clinically relevant equipment alarm, or technical failure.
  • Transport episodes not involving advanced respiratory support.
  • Transport episodes for which continuity of respiratory support or the primary technical feasibility outcome could not be determined.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Department Pulmonary Critical Care and Sleep Medicine Northwell Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

Location

Intensive care Unit, Hospital General Ramos Mejia, Buenos Aires Argentina School of Medicine, University of Magallanes

Punta Arenas, Chile

Location

Faculty of Health Sciences, Universidad Autónoma de Chile

Santiago, Chile

Location

Department of Anaesthesiology and ICU, University Hospital Centre Zagreb

Zagreb, Croatia

Location

Chest Department, Cairo University Hospitals

Cairo, Egypt

Location

Department of Respiratory Medicine, Father Muller Medical College Hospital

Mangalore, India

Location

Shahid Beheshti University of Medical Sciences

Tehran, Iran

Location

Department of Critical Care, UOC Anesthesia, Postoperative Intensive Care and ECMO, Monaldi Hospital, AORN Ospedali dei Colli

Naples, Italy

Location

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Servicio de Neumología

Mexico City, Mexico

Location

Department of Medicine, College of Medicine and Health Sciences, National University of Science and Technology

Sohar, Oman

Location

Heart Hospital, HMC

Doha, Qatar

Location

Department of Respiratory Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University

Jeddah, Saudi Arabia

Location

Mobile Emergency Unit of Albacete, Department of Urgent Care, Emergencies and Medical Transport of Castilla-La Mancha

Albacete, Spain

Location

Intensive Care Unit, Hospital Punta de Europa

Algeciras, Spain

Location

Emergentziak, Osakidetza

Bilbao, Spain

Location

Intensive Care Unit. Hospital Morales Meseguer

Murcia, Spain

Location

Department of Pulmonology, Tayfur Ata Sökmen Faculty of Medicine, Hatay Mustafa Kemal University

Hatay, Turkey (Türkiye)

Location

İstanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Al-Razi University

Sanaa, Yemen

Location

Department of Respiratory Therapy, Ibn- al-Nafis University for Medical Sciences

Sanaa, Yemen

Location

Related Publications (9)

  • 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: 30981603BACKGROUND
  • 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: 26781179BACKGROUND
  • 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: 23863225BACKGROUND
  • 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: 34535244BACKGROUND
  • 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: 34861515BACKGROUND
  • 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: 20470381BACKGROUND
  • 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: 14707589BACKGROUND
  • 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: 34649974BACKGROUND
  • 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: 28860265BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Antonio Esquinas

    Intensive Care Unit, Hospital Meseguer, Murcia, Spain

    STUDY DIRECTOR
  • Berkan Basançelebi

    Medipol University

    STUDY CHAIR
  • Satheesh Munusamy

    Heart Hospital, HMC, Qatar

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 25, 2026

First Posted

September 8, 2026

Study Start

February 20, 2023

Primary Completion

May 20, 2023

Study Completion

February 20, 2025

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data underlying the reported study results may be made available to qualified researchers upon reasonable request. Data sharing will be considered only for scientifically justified proposals and will be subject to approval by the HERMES Steering Committee, applicable ethics requirements, institutional policies, participant consent provisions, and relevant data-protection regulations. Data elements that could increase the risk of participant re-identification or that cannot be shared under applicable ethical, legal, or institutional requirements will not be provided. A data-use agreement may be required before access is granted.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Deidentified individual participant data and available supporting information may be made available beginning 6 months after publication of the primary study results and for up to 5 years thereafter.
Access Criteria
Deidentified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request. Requests must include a scientifically justified and methodologically appropriate research proposal and will be reviewed by the HERMES Steering Committee. Access will be limited to data necessary for the approved analysis and will remain subject to applicable ethics approvals, participant consent provisions, institutional policies, and data-protection regulations. Variables that cannot be adequately deidentified or are restricted by ethical, legal, or institutional requirements will not be shared. A data-use agreement may be required before access is granted.

Locations