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

2026年9月1日 更新者:Berkan Basançelebi、Medipol University

The HERMES Program: An International Multicenter Prospective Study of Quality and Safety During Transport of Patients Receiving Advanced Respiratory Support

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

565

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Successful Transport With Uninterrupted Respiratory Support
時間枠: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.
Day 1, during the transport episode from departure to arrival at the intended destination

二次結果の測定

結果測定
メジャーの説明
時間枠
Transport-Associated Adverse Events
時間枠:Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which at least one clinically relevant transport-associated adverse event occurs. Events will be prospectively documented and classified according to predefined study criteria as patient-related, respiratory-support-related, equipment-related, technical, organizational, or environmental events.
Day 1, during the transport episode from departure to arrival at the intended destination
Interruption or Unplanned Modification of Respiratory Support
時間枠:Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes requiring an unplanned temporary interruption, modification, replacement, or discontinuation of the respiratory-support strategy being delivered at departure. The type of event, reason for the modification, duration of interruption where measurable, and corrective action undertaken will be recorded.
Day 1, during the transport episode from departure to arrival at the intended destination
Escalation of Respiratory Support
時間枠:Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of patients requiring escalation to a higher level of respiratory support during transport because of clinical deterioration or inadequate respiratory support. Escalation may include transition from high-flow nasal oxygen to noninvasive ventilation or from noninvasive respiratory support to invasive mechanical ventilation. Other clinically relevant escalation pathways will be recorded according to the respiratory-support modality present at departure.
Day 1, during the transport episode from departure to arrival at the intended destination
Requirement for an Unplanned Rescue Intervention
時間枠:Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes requiring at least one unplanned rescue intervention in response to clinical deterioration, respiratory-support failure, equipment malfunction, oxygen limitation, electrical power limitation, airway-related problems, or another transport-associated event. Rescue interventions may include manual ventilation, emergency airway management, respiratory-interface adjustment or replacement, device replacement, change in respiratory-support modality, or another immediate corrective intervention.
Day 1, during the transport episode from departure to arrival at the intended destination
Clinically Relevant Physiologic Deterioration
時間枠:Day 1, from the pre-transport clinical assessment immediately before departure through arrival at the intended destination
Number and proportion of patients experiencing clinically relevant deterioration in one or more routinely monitored physiologic variables during transport. Variables may include oxygen saturation, respiratory rate, heart rate, blood pressure, level of consciousness, and other clinically available parameters. Clinically relevant deterioration will be defined prospectively according to prespecified thresholds and/or the requirement for corrective clinical intervention.
Day 1, from the pre-transport clinical assessment immediately before departure through arrival at the intended destination
Equipment-Related Alarms and Technical Events
時間枠:Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which a clinically relevant alarm or technical event involving respiratory-support, oxygen-delivery, monitoring, or transport equipment occurs. Events will include device malfunction, circuit or interface problems, accidental disconnection, equipment instability, clinically relevant alarms requiring intervention, or device replacement. Events resulting in interruption or modification of respiratory support will be identified separately.
Day 1, during the transport episode from departure to arrival at the intended destination
Electrical Power-Related Events
時間枠:Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which an electrical power-related event occurs, including unexpected battery depletion, insufficient remaining battery capacity, failure or loss of an intended power source, requirement for an unplanned change of power source, power-related device alarm requiring intervention, or interruption of respiratory-support equipment attributable to inadequate electrical power availability.
Day 1, during the transport episode from departure to arrival at the intended destination
Oxygen Supply-Related Events
時間枠:Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which an oxygen supply-related event occurs, including unexpected depletion or insufficiency of the planned oxygen reserve, requirement for an unplanned change of oxygen source, inability to provide the prescribed oxygen flow or concentration, or modification or interruption of respiratory support attributable to oxygen-supply limitations.
Day 1, during the transport episode from departure to arrival at the intended destination
Composite Transport Safety Event
時間枠:Day 1, during the transport episode from departure to arrival at the intended destination
Number and proportion of transport episodes in which at least one predefined clinically or technically relevant safety event occurs. The composite will include interruption or unplanned modification of prescribed respiratory support, clinically relevant physiologic deterioration, escalation of respiratory support, unplanned rescue intervention, equipment-related technical failure, electrical power-related event, or oxygen supply-related event. Individual components of the composite will also be reported separately.
Day 1, during the transport episode from departure to arrival at the intended destination

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Antonio M Esquinas、Intensive Care Unit, Hospital Meseguer, Murcia, Spain
  • スタディチェア:Berkan Basançelebi、İstanbul Medipol University, İstanbul, Türkiye
  • スタディチェア:Gaspar R. Chiappa、Faculty of Health Sciences, Universidad Autónoma de Chile, Providencia, Santiago, Chile

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月31日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年8月25日

QC基準を満たした最初の提出物

2026年9月1日

最初の投稿 (実際)

2026年9月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月4日

QC基準を満たした最後の更新が送信されました

2026年9月1日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Deidentified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the HERMES study steering committee and will require submission of a scientifically justified proposal and, where appropriate, execution of a data-use agreement. Data sharing will be subject to applicable ethical approvals, institutional policies, and national and international data-protection regulations.

IPD 共有時間枠

Deidentified individual participant data and the specified supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

IPD 共有アクセス基準

Deidentified IPD and supporting information will be available to qualified researchers who submit a scientifically justified and methodologically sound research proposal. Requests will be reviewed by the HERMES Steering Committee. Access will be granted only for approved research purposes and may require execution of a data-use agreement. Shared data will be limited to the variables necessary for the approved analysis and will be provided in a secure, deidentified format in accordance with applicable ethics approvals, institutional policies, and data-protection regulations.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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