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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.