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Completed

NCT Number: NCT07807189

HERMES: International Survey and Portable External Power Evaluation During Respiratory Support Transport

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

Patients receiving advanced respiratory support may require prehospital, interhospital, or intrahospital transport for diagnostic procedures, therapeutic interventions, transfer to a higher level of care, or continuation of acute management. Noninvasive ventilation and high-flow nasal oxygen are established forms of respiratory support in acute respiratory failure, while invasive mechanical ventilation remains necessary in patients with more severe or refractory respiratory failure. During transport, continuity of respiratory support must be maintained despite changes in environment, personnel, equipment configuration, oxygen availability, and electrical power supply.

Transport of critically ill patients represents a recognized period of increased clinical and technical vulnerability. International recommendations emphasize adequate stabilization before transport, appropriate physiologic monitoring, trained accompanying personnel, communication between clinical teams, verification of equipment function, sufficient oxygen and power reserves, and contingency planning for foreseeable clinical deterioration or device failure. Prospective cohort studies and systematic reviews have demonstrated that transport-associated adverse events may include physiologic deterioration, equipment malfunction, circuit or airway problems, interruptions in therapy, and organizational or communication failures. The reported frequency of such events varies substantially according to patient population, transport setting, event definitions, urgency, and surveillance methodology.

Against this background, the HERMES Phase I-II program was developed as two analytically distinct observational phases.

Phase I was an international electronic cross-sectional survey targeting healthcare professionals involved in NIV management or patient transport. The objective was to characterize reported clinical and organizational practices related to the transport of patients requiring noninvasive respiratory support and to identify perceived areas of vulnerability during transport.

The available survey records were timestamped from February 20 to May 6, 2023. The dataset contained 224 response records. Survey domains included indications for transport, type and positioning of ventilators, use of respiratory interfaces, composition of the transport team, and categories of patient-, equipment-, and environment-related problems.

The respondent record was the unit of analysis. Reported problems reflected respondents' perceptions or previous clinical experience and were therefore not interpreted as prospectively adjudicated adverse-event incidence. Because the available documentation did not establish the invitation denominator, recruitment channels, participating countries and institutions, reminder procedures, or a prespecified definition of questionnaire completion, a formal response rate and country- or institution-level prevalence estimates were not calculated.

The rationale for this phase was based on the recognized variability in transport organization and on the importance of standardized preparation, appropriately trained personnel, continuous monitoring, equipment checks, adequate resource planning, and predefined safety procedures. Structured transport protocols and checklists may further improve adherence to transport-safety recommendations and promote more consistent preparation before patient transfer.

Phase II was designed as a prospective descriptive feasibility evaluation of portable external electrical power during ambulance transport of patients requiring advanced respiratory support. Twenty-five transport episodes were prospectively recorded at participating units in Albacete and Bilbao, Spain. The cohort included 24 adults and one child.

Respiratory-support modalities included HFNO, rescue NIV, and invasive mechanical ventilation during cardiopulmonary resuscitation. A Zopec Transport UPS 90 external power supply was used during transport to support continuity of powered respiratory-support equipment. Respiratory-support devices, oxygen delivery, monitoring, and other aspects of clinical management remained determined by the treating clinical teams according to local practice.

The primary technical feasibility outcome was completion of ambulance transport while maintaining prescribed respiratory support without reported electrical power interruption, clinically relevant equipment alarm, or technical failure requiring corrective intervention. Additional descriptive variables included respiratory-support modality, transport duration, rescue respiratory support, technical events, operational complexity, and changes in respiratory support.

Electrical continuity represents an important component of transport safety because contemporary respiratory-support systems may depend simultaneou

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Phase I - International Healthcare Professional Survey

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Portable External Power Supply

Device

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.

Primary outcomes

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

    Time frame: Baseline

    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.

  2. Number and Percentage of Ambulance Transports Completed With Uninterrupted Respiratory Support

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

    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.

Secondary outcomes

  1. Number and Percentage of Respondents Reporting Transport-Related Problems

    Time frame: Baseline

    Number and percentage of Phase I survey respondents reporting patient-related, equipment-related, or environmental problems associated with respiratory-support transport. These responses reflected participants' reported perceptions or previous experience and did not represent prospectively adjudicated adverse-event incidence.

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

    Time frame: Baseline

    Number and percentage of Phase I survey respondents reporting the involvement of physicians, nurses, respiratory therapists, nursing assistants, or other healthcare personnel during respiratory-support transport. Multiple selections were permitted.

  3. Number and Percentage of Ambulance Transports by Respiratory-Support Modality

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

    Number and percentage of Phase II ambulance transport episodes involving high-flow nasal oxygen (HFNO), rescue noninvasive ventilation (NIV), or invasive mechanical ventilation.

  4. Number and Percentage of Patients Requiring Escalation or Modification of Respiratory Support

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

    Number and percentage of Phase II patients requiring escalation or clinically indicated modification of respiratory support during ambulance transport, including transition to rescue noninvasive ventilation or invasive mechanical ventilation.

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

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

    Number and percentage of Phase II ambulance transport episodes in which at least one electrical power interruption, clinically relevant equipment alarm, or technical failure was reported during use of the portable external power system.

  6. Ambulance Transport Duration in Minutes

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

    Duration of each Phase II ambulance transport episode, measured in minutes from departure from the point of origin to arrival at the intended destination. Transport duration was summarized using mean and standard deviation, median and interquartile range, and observed range.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Prehospital Transport During Advanced Respiratory Support: An International Survey and Prospective Feasibility Evaluation of Portable External Power

Acronym: HERMES

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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