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HERMES: International Survey and Portable External Power Evaluation During Respiratory Support Transport (HERMES)

2026年9月4日 更新者:Berkan Basançelebi、Medipol University

Prehospital Transport During Advanced Respiratory Support: An International Survey and Prospective Feasibility Evaluation of Portable External Power

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.

調査の概要

詳細な説明

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

研究の種類

観察的

入学 (実際)

246

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。

研究場所

    • New York
      • Mount Kisco、New York、アメリカ、10549
        • Department Pulmonary Critical Care and Sleep Medicine Northwell Northern Westchester Hospital
      • Sanaa、イエメン
        • Al-Razi University
      • Sanaa、イエメン
        • Department of Respiratory Therapy, Ibn- al-Nafis University for Medical Sciences
      • Naples、イタリア
        • Department of Critical Care, UOC Anesthesia, Postoperative Intensive Care and ECMO, Monaldi Hospital, AORN Ospedali dei Colli
      • Tehran、イラン
        • Shahid Beheshti University of Medical Sciences
      • Mangalore、インド
        • Department of Respiratory Medicine, Father Muller Medical College Hospital
      • Cairo、エジプト
        • Chest Department, Cairo University Hospitals
      • Sohar、オマーン
        • Department of Medicine, College of Medicine and Health Sciences, National University of Science and Technology
      • Doha、カタール
        • Heart Hospital, HMC
      • Zagreb、クロアチア
        • Department of Anaesthesiology and ICU, University Hospital Centre Zagreb
      • Jeddah、サウジアラビア
        • Department of Respiratory Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University
      • Albacete、スペイン
        • Mobile Emergency Unit of Albacete, Department of Urgent Care, Emergencies and Medical Transport of Castilla-La Mancha
      • Algeciras、スペイン
        • Intensive Care Unit, Hospital Punta de Europa
      • Bilbao、スペイン
        • Emergentziak, Osakidetza
      • Murcia、スペイン
        • Intensive Care Unit. Hospital Morales Meseguer
      • Punta Arenas、チリ
        • Intensive care Unit, Hospital General Ramos Mejia, Buenos Aires Argentina School of Medicine, University of Magallanes
      • Santiago、チリ
        • Faculty of Health Sciences, Universidad Autónoma de Chile
      • Hatay、トルコ(Türkiye)
        • Department of Pulmonology, Tayfur Ata Sökmen Faculty of Medicine, Hatay Mustafa Kemal University
      • Istanbul、トルコ(Türkiye)
        • Istanbul Medipol University
      • Mexico City、メキシコ
        • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Servicio de Neumología

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

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.

説明

Phase I - International Healthcare Professional Survey

Inclusion Criteria:

  • Healthcare professionals involved in the management of noninvasive ventilation or in the transport of patients requiring respiratory support.
  • Participation in the international electronic survey addressing respiratory-support transport practices.

Exclusion Criteria:

  • Records not representing participation in the respiratory-support transport survey.
  • Records lacking sufficient information for descriptive analysis of the predefined survey domains.

Phase II - Portable External Power Feasibility Evaluation

Inclusion Criteria:

  • Patients undergoing ambulance transport while receiving advanced respiratory support.
  • Receipt of high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or invasive mechanical ventilation during the transport episode.
  • Transport performed at one of the participating clinical units included in the prospective feasibility evaluation.
  • Availability of transport-level data sufficient to evaluate continuity of respiratory support and the occurrence of power interruption, clinically relevant equipment alarm, or technical failure.

Exclusion Criteria:

  • Transport episodes not involving advanced respiratory support.
  • Transport episodes for which continuity of respiratory support or the primary technical feasibility outcome could not be determined.

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
Phase I - International Healthcare Professional Survey
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.
Phase II - Portable External Power Feasibility Cohort
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.
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.

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
Number and Percentage of Respondents Reporting Predefined Respiratory-Support Transport Practices
時間枠:Baseline
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.
Baseline
Number and Percentage of Ambulance Transports Completed With Uninterrupted Respiratory Support
時間枠:From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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.
From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)

二次結果の測定

結果測定
メジャーの説明
時間枠
Number and Percentage of Respondents Reporting Transport-Related Problems
時間枠:Baseline
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.
Baseline
Number and Percentage of Respondents Reporting Each Transport-Team Professional Category
時間枠:Baseline
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.
Baseline
Number and Percentage of Ambulance Transports by Respiratory-Support Modality
時間枠:From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Number and percentage of Phase II ambulance transport episodes involving high-flow nasal oxygen (HFNO), rescue noninvasive ventilation (NIV), or invasive mechanical ventilation.
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
時間枠:From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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.
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
時間枠:From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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.
From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
Ambulance Transport Duration in Minutes
時間枠:From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 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.
From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)

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 Esquinas、Intensive Care Unit, Hospital Meseguer, Murcia, Spain
  • スタディチェア:Berkan Basançelebi、Medipol University
  • スタディチェア:Satheesh Munusamy、Heart Hospital, HMC, Qatar

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 (実際)

2023年2月20日

一次修了 (実際)

2023年5月20日

研究の完了 (実際)

2025年2月20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8日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月9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4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 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.

IPD 共有時間枠

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.

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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