The HERMES Program: An International Multicenter Prospective Study of Quality and Safety During Transport of Patients Receiving Advanced Respiratory Support
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 565
- 试验地点
- 4
- 主要终点
- Successful Transport With Uninterrupted Respiratory Support
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients Transported During Advanced Respiratory Support
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, according to routine clinical practice. Respiratory-support modality, monitoring, transport equipment, oxygen and electrical power resources, staffing, and all therapeutic decisions will be determined by the treating clinical team and will not be assigned by the study protocol. Clinical, physiologic, technical, organizational, and transport-related variables will be prospectively recorded throughout the transport episode.
干预措施: Advanced Respiratory Support During Patient Transport (Other)
结局指标
主要结局
Successful Transport With Uninterrupted Respiratory Support
时间窗: Day 1, during the transport episode from departure to arrival at the intended destination
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.
次要结局
- Transport-Associated Adverse Events(Day 1, during the transport episode from departure to arrival at the intended destination)
- Interruption or Unplanned Modification of Respiratory Support(Day 1, during the transport episode from departure to arrival at the intended destination)
- Escalation of Respiratory Support(Day 1, during the transport episode from departure to arrival at the intended destination)
- Requirement for an Unplanned Rescue Intervention(Day 1, during the transport episode from departure to arrival at the intended destination)
- Clinically Relevant Physiologic Deterioration(Day 1, from the pre-transport clinical assessment immediately before departure through arrival at the intended destination)
- Equipment-Related Alarms and Technical Events(Day 1, during the transport episode from departure to arrival at the intended destination)
- Electrical Power-Related Events(Day 1, during the transport episode from departure to arrival at the intended destination)
- Oxygen Supply-Related Events(Day 1, during the transport episode from departure to arrival at the intended destination)
- Composite Transport Safety Event(Day 1, during the transport episode from departure to arrival at the intended destination)
研究者
Berkan Basançelebi
Principal Investigator
Medipol University