An observational study in Patient Transport, Respiratory Failure and Noninvasive Ventilation, sponsored by Medipol University. Completed at 20 sites in 14 countries. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Medipol University · Observational
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.
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
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's enrollment of 246 is above the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.
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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.
Phase I - International Healthcare Professional Survey
Inclusion Criteria:
Exclusion Criteria:
Phase II - Portable External Power Feasibility Evaluation
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
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.
Time frame: 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.
Time frame: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Number and Percentage of Respondents Reporting Transport-Related Problems
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.
Time frame: Baseline
Number and Percentage of Respondents Reporting Each Transport-Team Professional Category
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.
Time frame: Baseline
Number and Percentage of Ambulance Transports by Respiratory-Support Modality
Number and percentage of Phase II ambulance transport episodes involving high-flow nasal oxygen (HFNO), rescue noninvasive ventilation (NIV), or invasive mechanical ventilation.
Time frame: 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
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.
Time frame: 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
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.
Time frame: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Ambulance Transport Duration in 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.
Time frame: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Plan to share: Yes — 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.
Supporting information: 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.
Ran from Feb 2023 to primary completion in May 2023, 3 months.
Of 232 non-industry observational studies under Respiratory Insufficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's 3 months is below that.
Counting every sponsor, half of 248 studies reached it within 22 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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