Observational Study Comparing Non-Invasive Mean Arterial Blood Pressure Measurements at the Arm and Ankle During Elective Cesarean Delivery to Facilitate Skin-to-Skin Contact.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Comparison of mean arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after birth.
研究概览
简要总结
This observational study aims to compare mean arterial pressure measurements obtained using an ankle blood pressure cuff with those obtained using a standard upper-arm cuff in pregnant individuals undergoing elective cesarean delivery under spinal anesthesia. The primary objective is to determine the level of agreement between the two measurement sites.The main question[s] it aims to answer [is/are]:
Demonstrate that the mean arterial pressure is similar between arm and ankle with the blood pressure cuff
Every participant will be their own control. (Measurements will be taken at both sites on every participant)
详细描述
Background Spinal anesthesia during elective cesarean delivery requires close monitoring of blood pressure to prevent maternal hypotension and decreased fetal perfusion. After birth, skin-to-skin contact offers several benefits, including improved well-being for the baby and support for breastfeeding initiation. The standard non-invasive blood pressure (BP) cuff on the arm can hinder comfortable and optimal positioning of the mother-infant dyad. This study aims to determine whether blood pressure measured by a non-invasive cuff on the ankle, five minutes after birth, is comparable to the standard measurement taken on the arm.
Objectives
Primary Objective:
Demonstrate a similar MAP between arm and ankle blood pressure measurements 5 minutes after birth
Secondary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled for elective cesarean under neuraxial anesthesia at CHU Sainte-Justine.
- •American Society of Anesthesiologists Physical Status I-III
- •Singleton pregnancy
- •Gestation ≥ 35 weeks
- •BMI < 40
- •Able to consent in French or English
排除标准
- •Cesarean planned under general anesthesia.
- •Multiple pregnancy
- •Prematurity < 35 weeks gestation
- •Major fetal anomalies
- •Morbid obesity (BMI ≥ 40)
- •Active labor
- •Emergency cesarean
- •Prisoners
- •Peripheral vascular disease requiring medication or treatment
- •Hypertensive diseases requiring medication
- •Inability to place blood pressure cuff on ankle (amputation, dysmorphism, etc.)
- •Complications requiring significant hemodynamic support (transfusions, inotropes, multiple vasopressors, etc.
研究组 & 干预措施
Cesarean delivery patients
Patients will have a blood pressure cuff on the arm and the ankle.
干预措施: Mean arterial pressure (Device)
结局指标
主要结局
Comparison of mean arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after birth.
时间窗: From enrollment (in the waiting room) to end of surgery
Comparison of mean arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after birth. This is to measure the outcome at a time point compatible with skin-to-skin for the mother-baby dyad.
次要结局
- Comparison in mean, systolic, diastolic arterial pressure taken by appropriately sized pressure cuffs between arm and ankle before neuraxial anesthesia, in the holding area.(From the waiting room to before neuraxial anesthesia)
- Comparison of mean, systolic, diastolic arterial pressure taken by appropriately sized blood pressure cuffs between arm and ankle taken 5 min after neuraxial anesthesia.(5 min after neuraxial anesthesia)
- Comparison in mean, systolic, diastolic arterial pressure taken by appropriately sized pressure cuffs between arm and ankle 10, 15, 20 minutes after birth.(10, 15, 20 minutes after birth)
- Assess maternal comfort and ease of skin-to-skin application with each blood pressure cuff (on the ankle and on the arm)(From enrollment in the waiting room to end of surgery)
研究者
Valerie Zaphiratos
Associate Professor of Anesthesiology
St. Justine's Hospital