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临床试验/NCT04671680
NCT04671680终止不适用

Comparison of Continuous Non-Invasive Arterial Blood Pressure to Invasive Arterial Blood Pressure Measurement in Pregnant Women With Placenta Accreta

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
1
主要终点
Comparing concordance between MAP from the CNAP and AIBP

研究概览

简要总结

The objective of this study is to investigate a technique to monitor blood pressure in women undergoing cesarean delivery with suspected placenta accreta spectrum. To achieve this objective, the investigators plan to conduct a prospective, observational study with the following aims:

Specific Aim 1: Compare concordance between the systolic (SBP), diastolic (DBP), and mean arterial blood pressure (MAP) readings from the continuous non-invasive arterial blood pressure (CNAP) and IABP at several discrete points throughout the procedure

Specific Aim 2: Determine the feasibility of using CNAP to aid in decision making by examining the parameters of volume responsiveness and arterial elastance at several discrete points throughout the procedure.

The investigators hypothesize that the investigators can obtain similar blood pressure monitoring using CNAP as compared to the gold standard IABP in women undergoing cesarean delivery with suspected placenta accreta.

详细描述

Study Overview This is a prospective, observational study.

Study Procedures Patients who meet inclusion criteria with no exclusions will be approached to provide written informed consent.

Enrolled patients will undergo the standard pre-operative evaluation and preparation for cesarean section with possible hysterectomy including evaluation by nursing, obstetrics and anesthesiology team, placement of 2 large bore IVs, arterial line placement and laboratory tests.

The patient will then be transported to the OR. In the OR the CNAP device will be placed on the patient's finger and be given a brief calibration period of 45 seconds. As per usual for this procedure, each patient will undergo combined spinal epidural anesthesia with our standard cesarean induction dose of hyperbaric intrathecal 0.75% bupivacaine 1.5ml, intrathecal fentanyl 25 micrograms and intrathecal morphine 250 micrograms. The patient will be moved to the supine position with left lateral uterine displacement. When a T6 sensory level to pinprick is achieved, surgery will be allowed to proceed. Throughout the surgery, the CNAP and IABP will take continuous reading of blood pressure and hemodynamic variable. Labs and additional fluid or blood may be given to the patient as clinically indicated, as is common for this procedure. Blood work will be obtained from the arterial line used for IABP, as is standard practice when an AIBP is in place. Other than the addition of the CNAP cuff, all other care will be per standard protocol for this procedure.

Data Collection In order to assess our primary and secondary outcomes, the investigators will be collecting CNAP and AIBP. Additional baseline characteristics including, but not limited to age, race, gender, BMI and comorbidities will be abstracted from the medical record. REDCap will be utilized for data collection and storage.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-40 years old with pregnancy complicated by accreta spectrum undergoing elective, scheduled cesarean delivery and possible hysterectomy

排除标准

  • Women aged <18
  • Patients with cardiac arrhythmia
  • Vascular pathologies of the upper limbs (recent vascular surgery, Reynaud's disease, vascular stenosis)
  • Contraindication to neuraxial anesthesia
  • Emergent cases
  • Droplet or airborne precautions (as determined by BIDMC infection control policy)

结局指标

主要结局

Comparing concordance between MAP from the CNAP and AIBP

时间窗: MAP will be measured continuously throughout the operative case, with an average case timeframe of 4-6 hours.

Comparing concordance of systolic blood pressure, mean arterial blood pressure, and diastolic blood pressure readings captured from the continuous non-invasive arterial blood pressure measurements and invasive arterial blood pressure measurements.

次要结局

  • Stroke Volume Variation(Measured throughout the operative case, with an average case timeframe of 4-6 hours.)
  • Stroke Volume(Measured throughout the operative case, with an average case timeframe of 4-6 hours.)
  • Additional Comparisons of SBP and DBP(SBP and DBP will be measured continuously throughout the operative case, with an average case timeframe of 4-6 hours.)
  • Systemic Vascular Resistance(Measured throughout the operative case, with an average case timeframe of 4-6 hours.)
  • Subgroup analysis of CNAP and AIBP(Measured throughout the operative case, with an average case timeframe of 4-6 hours.)
  • Cardiac Output(Measured throughout the operative case, with an average case timeframe of 4-6 hours.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip Hess

Associate Professor of Anaesthesia

Beth Israel Deaconess Medical Center

研究点 (1)

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