The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
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: Cesarean Delivery, General Anesthesia. Базовые параметры: 15 лет — 55 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery.
Подробное описание
This is a central repository with data from 25-40 participating SOAP institutions/hospitals.
The primary and secondary aims of this study are as follows:
1. To determine the institutional factors associated with rates of general anesthesia for cesarean delivery 2. To perform a descriptive analysis of characteristics of general anesthesia for cesarean delivery cases 3. To determine maternal and anesthetic predictors of difficult intubation
Data will be collected from each participating SOAP institution. Institutional data will include information on the characteristics of the institution such as maternal level of care, numbers of lives birth, staffing models, etc. This data will be collected prior to subjects being enrolled into the registry and again at the registry closure to look at intuitional changes over time.
Inclusion into the registry is based on the following criteria:
1. Pregnant women who have had a general anesthetic for Cesarean delivery 2. 15-55 years old
The general anesthesia registry will collect data on subject demographics in a deidentified manner, including characteristics of the birth and delivery, gestational age, maternal morbidities, and anesthetic management.
The granular detail requested in the registry database will help to better understand the nuances of how and why decisions are made about proceeding with general anesthesia in these cases, and once done, how to implement this clinical course. As not all of these data points are routinely recorded in the medical record, optimal data capture requires the treating anesthesiologist to complete the registry entry as soon as possible after conclusion of patient care.
Data will be collected for approximately 5 years and maintained indefinitely. Data is entered into a Yale REDCap registry and will not contain subject identifiers. An estimated 5000 subjects will be enrolled into the data repository. This is based on a published report of 45 institutions' data investigating a subtopic of this question (15 years yielding 15,000 general anesthetics).
Первичные конечные точки
- Rates of General Anesthesia for Cesarean Delivery [Срок оценки: Up to 5 years]
- Univariate Association Between Facility Type and the Rate of General Anesthesia for Cesarean Delivery [Срок оценки: Up to 5 years]
- Univariate Association Between SOAP Center of Excellence Designation and the Rate of General Anesthesia for Cesarean Delivery [Срок оценки: Up to 5 years]
- Univariate Association Between Maternal Level of Care and the Rate of General Anesthesia for Cesarean Association [Срок оценки: Up to 5 years]
- Univariate Association Between Annual Live Births and the Rate of General Anesthesia for Cesarean Delivery [Срок оценки: Up to 5 years]
- Univariate Association Between Obstetric Anesthesiologist Coverage and the Rate of General Anesthesia for Cesarean Delivery [Срок оценки: Up to 5 years]
- Univariate Association Between Institutional Policies for Labor Epidural Management and the Rate of General Anesthesia for Cesarean Delivery [Срок оценки: Up to 5 years]
Вторичные конечные точки (6)
- Rates of Difficult Intubation Among Women Undergoing General Anesthesia for Cesarean Delivery [Срок оценки: Up to 5 years]
- Univariate Association Between Mallampati Score and the Risk of Difficult Intubation [Срок оценки: Up to 5 years]
- Univariate Association Between Neck Mobility and the Risk of Difficult Intubation [Срок оценки: Up to 5 years]
- Univariate Association Between Neck Circumference and the Risk of Difficult Intubation [Срок оценки: Up to 5 years]
- Univariate Association Between Neck Length and the Risk of Difficult Intubation [Срок оценки: Up to 5 years]
- Univariate Association Between Thyromental Distance and the Risk of Difficult Intubation [Срок оценки: Up to 5 years]
Критерии участия
Критерии включения
-Pregnant women aged 15-55 who have had a general anesthetic for Cesarean delivery
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Экологическое
Центры проведения
США · 34 центра
- University of Arkansas — Little Rock
- University of California San Francisco — San Francisco
- Stanford University — Stanford
- University of Colorado Hospital — Arvada
- Yale University — New Haven
- University of Florida — Gainesville
- St Lukes Anesthesia Associates of Boise — Boise
- University of Chicago Medical Center — Chicago
- … и ещё 26 центров
Канада · 1 центр
- Royal Columbian Hospital & University of British Columbia — New Westminster
Идентификаторы
NCT: NCT06030063 · 2000033638