- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07814131
Surgical Apgar Score for Identifying Patients Who May Need Intensive Care After Emergency Abdominal Surgery (SAS-ICU)
Surgical Apgar Score Predicts ICU Admission After Emergency General Surgery Laparotomy
Обзор исследования
Статус
Подробное описание
Emergency general surgery laparotomy is associated with a substantial risk of postoperative complications and may require postoperative intensive care. In resource-limited healthcare settings, appropriate identification of patients who are likely to require intensive care may assist in postoperative triage and rational allocation of limited critical care resources.
The Surgical Apgar Score (SAS) is a simple 10-point perioperative risk score calculated using three intraoperative parameters: estimated blood loss, lowest mean arterial pressure, and lowest heart rate. Lower scores have been associated with increased postoperative morbidity and mortality in several surgical populations. Previous studies have also reported an association between low SAS and direct postoperative intensive care unit admission. However, evidence regarding its utility among patients undergoing emergency general surgery laparotomy in the local setting is limited.
This study will prospectively observe patients undergoing emergency exploratory laparotomy at Mayo Hospital Lahore and evaluate the relationship between the Surgical Apgar Score and direct postoperative intensive care unit admission. The score will be calculated immediately after surgery using routinely documented intraoperative parameters. Patients will subsequently be categorized according to their SAS, with scores of 7 or less classified as low and scores greater than 7 classified as high.
The study will determine the frequency of direct intensive care unit admission and assess whether patients with a low Surgical Apgar Score are more likely to require direct postoperative intensive care than those with a higher score. Relevant demographic and clinical characteristics will also be recorded to allow assessment of factors that may influence the relationship between SAS and intensive care admission.
The findings may help determine whether the Surgical Apgar Score can serve as a simple and readily available tool for identifying emergency laparotomy patients at increased risk of requiring postoperative intensive care. This may support more objective postoperative triage and resource allocation in high-volume, resource-constrained surgical settings.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Mahnoor Dr Wasim, MBBS, MRCSEd, CHPE
- Номер телефона: +923075275080
- Электронная почта: mahnoorwsm@gmail.com
Учебное резервное копирование контактов
- Имя: Dr Zeeshan sarwar, MBBS, FCPS
- Номер телефона: +923228420433
- Электронная почта: mzeeshansarwar@gmail.com
Места учебы
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Punjab Province
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Lahore, Punjab Province, Пакистан, 54000
- Mayo Hospital Lahore
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Контакт:
- dr zeeshan sarwar, MBBS, FCPS
- Номер телефона: +923075275080
- Электронная почта: mzeeshansarwar@gmail.com
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Контакт:
- dr zeeshan sarwar, MBBS, FCPS
- Электронная почта: mzeeshansarwar@gmail.com
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Главный следователь:
- Mahnoor dr Wasim, MBBS, MRCSEd, CHPE
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Male and female patients aged 13 to 89 years. Patients undergoing emergency exploratory laparotomy at Mayo Hospital Lahore for an emergency general surgery indication.
Patients undergoing laparotomy within 8 hours of surgical evaluation. Patients with emergency general surgery pathologies including gastrointestinal perforation, intestinal obstruction, ischemia, intra-abdominal sepsis, and blunt or penetrating abdominal trauma.
Patients who provide informed consent for participation.
Exclusion Criteria:
- Patients transferred from another emergency institution when more than 8 hours have elapsed since initial presentation.
Patients who do not undergo emergency exploratory laparotomy. Patients who do not have sufficient intraoperative data to calculate the Surgical Apgar Score.
Patients for whom postoperative disposition to ICU or another postoperative location cannot be determined.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Low Surgical Apgar Score (≤7)
Participants undergoing emergency exploratory laparotomy who have a Surgical Apgar Score of ≤7, calculated immediately after surgery from estimated blood loss, lowest mean arterial pressure, and lowest heart rate recorded during the operation.
This cohort will be observed for direct admission to the intensive care unit following surgery.
No intervention is assigned as part of the study.
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High Surgical Apgar Score (>7)
Participants undergoing emergency exploratory laparotomy who have a Surgical Apgar Score of >7, calculated immediately after surgery from estimated blood loss, lowest mean arterial pressure, and lowest heart rate recorded during the operation.
This cohort will be observed for direct admission to the intensive care unit following surgery.
No intervention is assigned as part of the study.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Direct Postoperative Intensive Care Unit Admission
Временное ограничение: Within 1 hour after completion of surgery
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The proportion of patients transferred directly from the operating room to the Intensive Care Unit immediately following emergency exploratory laparotomy.
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Within 1 hour after completion of surgery
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Association of Surgical Apgar Score category with direct postoperative ICU admission
Временное ограничение: Perioperative/Periprocedural
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The proportion of patients with a low Surgical Apgar Score (≤7) will be compared with patients with a high Surgical Apgar Score (>7) to determine the association between SAS category and direct admission to the intensive care unit following emergency general surgery laparotomy.
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Perioperative/Periprocedural
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: dr zeeshan sarwar, King Edward Medical University
Публикации и полезные ссылки
Общие публикации
- Tracy BM, Srinivas S, Baselice H, Gelbard RB, Coleman JR. Surgical Apgar scores predict complications after emergency general surgery laparotomy. J Trauma Acute Care Surg. 2024 Mar 1;96(3):429-433. doi: 10.1097/TA.0000000000004189. Epub 2023 Nov 8.
- Lin YC, Chen YC, Yang CH, Su NY. Surgical Apgar score is strongly associated with postoperative ICU admission. Sci Rep. 2021 Jan 8;11(1):115. doi: 10.1038/s41598-020-80393-z.
- Gawande AA, Kwaan MR, Regenbogen SE, Lipsitz SA, Zinner MJ. An Apgar score for surgery. J Am Coll Surg. 2007 Feb;204(2):201-8. doi: 10.1016/j.jamcollsurg.2006.11.011. Epub 2006 Dec 27.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Другие идентификационные номера исследования
- 2023-7628
Планирование данных отдельных участников (IPD)
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Описание плана IPD
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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