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Набор скоро начнётся NCT07610915

Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit

— Наблюдательное Postoperative Recovery in Children

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: Postoperative Recovery in Children. Базовые параметры: 2 лет — 17 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
Таиланд
Следующий шаг
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Официальное название

Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)

Обзор

This project aims to develop and test a new questionnaire to measure how well children recover in the post-anaesthesia care unit (PACU). Currently, children in PACU are mainly assessed using discharge readiness criteria, but these do not fully capture the child's recovery experience or overall wellbeing. Participants will be children aged 2-17 years having elective procedures requiring anaesthesia or sedation, and their parents/caregivers where proxy reporting is needed for younger children. The study will be conducted in stages, including interviews to identify important aspects of recovery, expert review of draft questions, testing of question clarity and acceptability, and field testing of the questionnaire in PACU at planned time points during recovery. Clinical information routinely collected as part of care, such as pain scores, nausea vomiting, airway or oxygen events, and length of stay in PACU, will also be examined to assess how well the questionnaire performs. The expected outcome is a child-centred, practical, and reliable PACU recovery measure that can be used in clinical care, quality improvement, and future research.

Подробное описание

This project aims to address an important gap in paediatric postoperative care. Children recovering in the post-anaesthesia care unit (PACU) are commonly assessed using physiologic discharge-readiness criteria, which focus mainly on safety parameters such as consciousness, breathing, circulation, and readiness to leave PACU. Although these measures are essential for clinical decision-making, they do not fully capture the child's actual recovery experience, including symptoms such as pain, nausea or vomiting, distress, discomfort, tiredness, or poor behavioural recovery. As a result, two children may both meet discharge criteria yet have very different quality of recovery.

At present, there is no well-established child-centred questionnaire designed specifically to measure quality of recovery during the immediate PACU period. This project therefore aims to develop and test a new questionnaire that better reflects what matters to children, families, and clinicians during early recovery after anaesthesia and surgery.

The study will include children aged 2-17 years undergoing elective procedures requiring anaesthesia or sedation, with parent/caregiver proxy reporting used where appropriate for younger children. This is a multicentre collaboration. The Siriraj Hospital site will be involved in Step 1, the qualitative item-generation phase, and Step 4, the field-testing / survey administration phase. In Step 1, interviews with children, parents/caregivers, and clinicians will identify the most important aspects of recovery. In Step 4, the questionnaire will be tested in PACU and compared with routinely collected clinical indicators. The expected outcome is a practical, reliable, and child-centred PACU recovery measure for use in clinical care, quality improvement, and future research.

Первичные конечные точки

  • PedsQoR-PACU questionnaire score [Срок оценки: Perioperative/Periprocedural (Day of surgery)]
Вторичные конечные точки (4)
  • Internal consistency of the PedsQoR-PACU questionnaire [Срок оценки: Perioperative/Periprocedural (Day of surgery)]
  • Test-retest reliability of the PedsQoR-PACU questionnaire [Срок оценки: Perioperative/Periprocedural (Day of surgery)]
  • Child-parent agreement for the PedsQoR-PACU questionnaire score [Срок оценки: Perioperative/Periprocedural (Day of surgery)]
  • Construct validity of the PedsQoR-PACU questionnaire score [Срок оценки: Perioperative/Periprocedural (Day of surgery)]

Критерии участия

Критерии включения

  • Children aged 8-17 years for self-report version
  • Parents/caregivers of children aged 2-7 years for proxy-report version
  • Elective surgery/procedure under anaesthesia
  • Planned recovery in PACU
  • ASA I-IV
  • Able to communicate in the prespecified site language (Thai - in Siriraj Hospital site)
  • Informed consent/assent obtained as applicable Exclusion criteria
  • Unable to communicate in the prespecified site language (Thai - in Siriraj Hospital site)
  • Urgent or emergency surgery/procedure
  • Not planned to recover in PACU, including planned direct transfer from theatre to ICU
  • Developmental delay or other condition limiting comprehension for interview participation or questionnaire completion
  • Not available for an uninterrupted interview or questionnaire completion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Таиланд · 1 центр
  • Siriraj Hospital — Bangkok Noi

Идентификаторы

NCT: NCT07610915 · 433/2569(IRB4)

Первоисточники (государственные реестры)

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