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Набор скоро начнётся NCT07299968

Accuracy of the Welch Allyn ConnexSpot Monitor in Measuring Respiratory Rate in the Emergency Department

— Наблюдательное Respiratory Rate Breathing Rate

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Respiratory Rate, Breathing Rate. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Венгрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of the Welch Allyn Connex Spot Monitor in Measuring Respiratory Rate in the Emergency Department: a Prospective Observational Study Protocol

Обзор

This prospective observational study will evaluate the accuracy of the Welch Allyn Connex Spot Monitor equipped with a Masimo SpO₂ finger sensor in measuring respiratory rate in the emergency department. Respiratory rate is a key predictor of patient deterioration, yet it is frequently measured inaccurately when assessed manually. In this study, respiratory rate values obtained by the monitor will be compared against manual counts performed by trained observers (physicians). An additional analysis will compare respiratory rates measured by trained observers with those recorded by triage nurses during triage. A subgroup analysis will also investigate whether cardiac arrhythmias influence measurement accuracy. The aim is to examine if respiratory rates measured by the Welch Allyn Connex Spot Monitor are comparable to those obtained by trained observers and triage nurses in the emergency department.

Подробное описание

Design: prospective observational method comparison study

Первичные конечные точки

  • Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers (reference standard) [Срок оценки: During the emergency department visit (single measurement per participant).]
Вторичные конечные точки (2)
  • Agreement between respiratory rate values measured by trained observers and those recorded by triage nurses during triage [Срок оценки: During the emergency department visit (single measurement per participant).]
  • Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers in patients with ECG-confirmed arrhytmias [Срок оценки: During the emergency department visit (single measurement per participant).]

Критерии участия

Критерии включения

\- all patients aged ≥18 years.

Критерии исключения

  • patients receiving invasive or non-invasive respiratory support;
  • patients with disorders causing involuntary movements;
  • skin or digit abnormalities preventing proper application of the pulse oximeter;
  • clinically unstable patients on arrival (requiring immediate transfer to the resuscitation area);
  • patients with a left ventricular assist device (LVAD).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Венгрия · 1 центр
  • Department of Emergency Medicine, Semmelweis University — Budapest

Публикации

  • Semler MW, Stover DG, Copland AP, Hong G, Johnson MJ, Kriss MS, Otepka H, Wang L, Christman BW, Rice TW. Flash mob research: a single-day, multicenter, resident-directed study of respiratory rate. Chest. 2013 Jun;143(6):1740-1744. doi: 10.1378/chest.12-1837. PMID 23197319
  • Loots FJ, Dekker I, Wang RC, van Zanten AR, Hopstaken RM, Verheij TJ, Giesen P, Smits M. The accuracy and feasibility of respiratory rate measurements in acutely ill adult patients by GPs: a mixed-methods study. BJGP Open. 2022 Dec 20;6(4):BJGPO.2022.0029. doi: 10.3399/BJGPO.2022.0029. Print 2022 Dec. PMID 35944945
  • Edmonds ZV, Mower WR, Lovato LM, Lomeli R. The reliability of vital sign measurements. Ann Emerg Med. 2002 Mar;39(3):233-7. doi: 10.1067/mem.2002.122017. PMID 11867974
  • Badawy J, Nguyen OK, Clark C, Halm EA, Makam AN. Is everyone really breathing 20 times a minute? Assessing epidemiology and variation in recorded respiratory rate in hospitalised adults. BMJ Qual Saf. 2017 Oct;26(10):832-836. doi: 10.1136/bmjqs-2017-006671. Epub 2017 Jun 26. PMID 28652259
  • Leuvan CH, Mitchell I. Missed opportunities? An observational study of vital sign measurements. Crit Care Resusc. 2008 Jun;10(2):111-15. PMID 18522524
  • Churpek MM, Yuen TC, Park SY, Meltzer DO, Hall JB, Edelson DP. Derivation of a cardiac arrest prediction model using ward vital signs*. Crit Care Med. 2012 Jul;40(7):2102-8. doi: 10.1097/CCM.0b013e318250aa5a. PMID 22584764
  • Goldhill DR, McNarry AF, Mandersloot G, McGinley A. A physiologically-based early warning score for ward patients: the association between score and outcome. Anaesthesia. 2005 Jun;60(6):547-53. doi: 10.1111/j.1365-2044.2005.04186.x. PMID 15918825
  • Mochizuki K, Shintani R, Mori K, Sato T, Sakaguchi O, Takeshige K, Nitta K, Imamura H. Importance of respiratory rate for the prediction of clinical deterioration after emergency department discharge: a single-center, case-control study. Acute Med Surg. 2016 Nov 10;4(2):172-178. doi: 10.1002/ams2.252. eCollection 2017 Apr. PMID 29123857

Идентификаторы

NCT: NCT07299968 · SOK-LEGZ25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗