- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07807189
HERMES: International Survey and Portable External Power Evaluation During Respiratory Support Transport (HERMES)
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Cairo, Египет
- Chest Department, Cairo University Hospitals
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Mangalore, Индия
- Department of Respiratory Medicine, Father Muller Medical College Hospital
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Tehran, Иран
- Shahid Beheshti University of Medical Sciences
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Albacete, Испания
- Mobile Emergency Unit of Albacete, Department of Urgent Care, Emergencies and Medical Transport of Castilla-La Mancha
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Algeciras, Испания
- Intensive Care Unit, Hospital Punta de Europa
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Bilbao, Испания
- Emergentziak, Osakidetza
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Murcia, Испания
- Intensive Care Unit. Hospital Morales Meseguer
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Naples, Италия
- Department of Critical Care, UOC Anesthesia, Postoperative Intensive Care and ECMO, Monaldi Hospital, AORN Ospedali dei Colli
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Sanaa, Йемен
- Al-Razi University
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Sanaa, Йемен
- Department of Respiratory Therapy, Ibn- al-Nafis University for Medical Sciences
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Doha, Катар
- Heart Hospital, HMC
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Mexico City, Мексика
- Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Servicio de Neumología
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Sohar, Оман
- Department of Medicine, College of Medicine and Health Sciences, National University of Science and Technology
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Jeddah, Саудовская Аравия
- Department of Respiratory Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University
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New York
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Mount Kisco, New York, Соединенные Штаты, 10549
- Department Pulmonary Critical Care and Sleep Medicine Northwell Northern Westchester Hospital
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Hatay, Турция (Туркие)
- Department of Pulmonology, Tayfur Ata Sökmen Faculty of Medicine, Hatay Mustafa Kemal University
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Istanbul, Турция (Туркие)
- Istanbul Medipol University
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Zagreb, Хорватия
- Department of Anaesthesiology and ICU, University Hospital Centre Zagreb
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Punta Arenas, Чили
- Intensive care Unit, Hospital General Ramos Mejia, Buenos Aires Argentina School of Medicine, University of Magallanes
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Santiago, Чили
- Faculty of Health Sciences, Universidad Autónoma de Chile
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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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.
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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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Number and Percentage of Respondents Reporting Predefined Respiratory-Support Transport Practices
Временное ограничение: Baseline
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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.
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Baseline
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Number and Percentage of Ambulance Transports Completed With Uninterrupted Respiratory Support
Временное ограничение: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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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.
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From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Number and Percentage of Respondents Reporting Transport-Related Problems
Временное ограничение: Baseline
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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.
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Baseline
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Number and Percentage of Respondents Reporting Each Transport-Team Professional Category
Временное ограничение: Baseline
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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.
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Baseline
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Number and Percentage of Ambulance Transports by Respiratory-Support Modality
Временное ограничение: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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Number and percentage of Phase II ambulance transport episodes involving high-flow nasal oxygen (HFNO), rescue noninvasive ventilation (NIV), or invasive mechanical ventilation.
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From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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Number and Percentage of Patients Requiring Escalation or Modification of Respiratory Support
Временное ограничение: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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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.
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From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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Number and Percentage of Ambulance Transports With Power Interruption, Clinically Relevant Equipment Alarm, or Technical Failure
Временное ограничение: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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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.
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From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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Ambulance Transport Duration in Minutes
Временное ограничение: From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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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.
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From departure from the point of origin to arrival at the intended destination (transport duration: 23-110 minutes)
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Antonio Esquinas, Intensive Care Unit, Hospital Meseguer, Murcia, Spain
- Учебный стул: Berkan Basançelebi, Medipol University
- Учебный стул: Satheesh Munusamy, Heart Hospital, HMC, Qatar
Публикации и полезные ссылки
Общие публикации
- Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
- Schwebel C, Clec'h C, Magne S, Minet C, Garrouste-Orgeas M, Bonadona A, Dumenil AS, Jamali S, Kallel H, Goldgran-Toledano D, Marcotte G, Azoulay E, Darmon M, Ruckly S, Souweine B, Timsit JF; OUTCOMEREA Study Group. Safety of intrahospital transport in ventilated critically ill patients: a multicenter cohort study*. Crit Care Med. 2013 Aug;41(8):1919-28. doi: 10.1097/CCM.0b013e31828a3bbd.
- Warren J, Fromm RE Jr, Orr RA, Rotello LC, Horst HM; American College of Critical Care Medicine. Guidelines for the inter- and intrahospital transport of critically ill patients. Crit Care Med. 2004 Jan;32(1):256-62. doi: 10.1097/01.CCM.0000104917.39204.0A.
- Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
- Murata M, Nakagawa N, Kawasaki T, Yasuo S, Yoshida T, Ando K, Okamori S, Okada Y. Adverse events during intrahospital transport of critically ill patients: A systematic review and meta-analysis. Am J Emerg Med. 2022 Feb;52:13-19. doi: 10.1016/j.ajem.2021.11.021. Epub 2021 Nov 20.
- Jeyaraju M, Andhavarapu S, Palmer J, Bzhilyanskaya V, Friedman E, Lurie T, Patel P, Raffman A, Wang J, Tran QK. Safety Matters: A Meta-analysis of Interhospital Transport Adverse Events in Critically Ill Patients. Air Med J. 2021 Sep-Oct;40(5):350-358. doi: 10.1016/j.amj.2021.04.008. Epub 2021 May 24.
- Williams P, Karuppiah S, Greentree K, Darvall J. A checklist for intrahospital transport of critically ill patients improves compliance with transportation safety guidelines. Aust Crit Care. 2020 Jan;33(1):20-24. doi: 10.1016/j.aucc.2019.02.004. Epub 2019 Apr 10.
- Jia L, Wang H, Gao Y, Liu H, Yu K. High incidence of adverse events during intra-hospital transport of critically ill patients and new related risk factors: a prospective, multicenter study in China. Crit Care. 2016 Jan 18;20:12. doi: 10.1186/s13054-016-1183-y.
- Fanara B, Manzon C, Barbot O, Desmettre T, Capellier G. Recommendations for the intra-hospital transport of critically ill patients. Crit Care. 2010;14(3):R87. doi: 10.1186/cc9018. Epub 2010 May 14.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
- Безопасность пациентов
- Механическая вентиляция
- Неинвазивная вентиляция
- Респираторная поддержка
- Назальный кислород с высоким потоком
- Patient Transport
- Intrahospital Transport
- Interhospital Transport
- Prehospital Transport
- Transport Safety
- Critical Care Transport
- Electrical Power Continuity
- Advanced Respiratory Support
- Portable External Power
- Equipment-Related Events
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IANIV-HERMES-I-II
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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