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

ConditionsAcute 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

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorMedipol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing a clinically indicated prehospital, interhospital, or intrahospital transport.

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Advanced Respiratory Support During Patient Transport
Other intervention
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.

Treatment groups

565 Participants

are divided into 1 treatment group

Group A: Patients Transported During Advanced Respiratory Support1 intervention

Trial outcomes

Primary outcomes

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.

Time frame