Accuracy of Non-Invasive Blood Pressure Monitoring During Video-Assisted Thoracoscopic Surgery With One-Lung Ventilation: A Prospective Error Grid Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Proportion of Paired Systolic Blood Pressure Measurements Within Zone A of the Error Grid
研究概览
简要总结
This study will test how accurate a blood pressure cuff is during a specific type of chest surgery.
In some lung surgeries, doctors use a method called video-assisted thoracoscopic surgery (VATS), where small tools and a camera are inserted through the chest wall. During these procedures, patients often have only one lung ventilated to give the surgeon more space to work. This setup can affect how well a blood pressure cuff on the arm reflects the true blood pressure inside the body.
This study will compare readings from the arm cuff (non-invasive) with those from a thin tube placed inside an artery (invasive), which is more accurate but also more uncomfortable and carries some risks.
Researchers will use a method called error grid analysis to see how closely the cuff readings match the invasive ones. They want to find out if the cuff is accurate enough to be used safely in these surgeries. If it is, patients might not need an invasive line as often in the future.
People 18 years or older who are already going to have invasive blood pressure monitoring during planned thoracic surgery with one-lung ventilation may be able to join the study. The research team will collect blood pressure measurements about every 20 minutes during surgery, as well as basic information like age, weight, and what medications are given.
详细描述
This is a prospective observational study designed to evaluate the clinical accuracy and reliability of non-invasive blood pressure (NIBP) monitoring in adult patients undergoing video-assisted thoracoscopic surgery (VATS) with one-lung ventilation (OLV). The accuracy of NIBP will be assessed by comparing it to invasive arterial blood pressure (IABP), which is considered the reference standard. The comparison will be performed using error grid analysis, a method that not only quantifies measurement differences but also categorizes the clinical risk of those discrepancies.
During VATS procedures, one lung is intentionally deflated to improve surgical access, which alters thoracic pressures, ventilation dynamics, and cardiovascular physiology. These changes may affect the accuracy of peripheral blood pressure measurements obtained using an arm cuff. Previous evaluations of NIBP in surgical patients have primarily relied on Bland-Altman analysis, which measures statistical agreement but does not assess the clinical consequences of disagreement between methods.
Error grid analysis overcomes this limitation by mapping paired NIBP and IABP values into predefined clinical risk zones (A-E), based on their potential to affect treatment decisions. Zone A represents measurements with no risk of causing inappropriate treatment, while Zones B through E indicate increasing levels of clinical risk due to measurement error.
In this study, NIBP and IABP measurements will be recorded simultaneously approximately every 20 minutes throughout surgery. The percentage of measurements that fall within each error grid zone will be calculated. If fewer than 90% of the paired measurements fall within Zone A, NIBP will be considered insufficiently reliable for use without concurrent invasive monitoring in this clinical context.
A pilot study of five patients was used to estimate the intracluster correlation coefficient and design effect, which informed the final sample size calculation. Based on these preliminary data, a total sample size of 90 patients is estimated to provide adequate statistical power to evaluate the primary outcome with 95% confidence and a 5% margin of error.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Scheduled to undergo video-assisted thoracoscopic surgery with one-lung ventilation
- •Will receive invasive arterial blood pressure monitoring as part of routine clinical care
排除标准
- •Has peripheral artery disease
- •Has congestive heart failure
结局指标
主要结局
Proportion of Paired Systolic Blood Pressure Measurements Within Zone A of the Error Grid
时间窗: Intraoperative period (measurements taken every 20 minutes during surgery)
The percentage of systolic non-invasive blood pressure (NIBP) measurements that fall within Zone A of the consensus error grid with calibrated risk zones, as described by Saugel et al.\[1\]. Zone A represents measurement pairs with no risk of leading to inappropriate clinical decisions, based on comparison with simultaneously recorded systolic invasive arterial blood pressure values. Systolic NIBP measurements will be considered acuurate if 90% or more of the paired values fall within Zone A. 1. Saugel B, Grothe O, Nicklas JY. Error Grid Analysis for Arterial Pressure Method Comparison Studies. Anesth Analg. 2018 Apr;126(4):1177-1185
Proportion of Paired Mean Arterial Pressure (MAP) Measurements Within Zone A of the Error Grid
时间窗: Intraoperative period (measurements taken every 20 minutes during surgery)
The percentage of non-invasive mean arterial pressure (MAP) measurements that fall within Zone A of the consensus error grid with calibrated risk zones, as described by Saugel et al.\[1\]. Zone A represents measurement pairs with no risk of leading to inappropriate clinical decisions, based on comparison with simultaneously recorded invasive MAP values. Non-invasive MAP measurements will be considered accurate if 90% or more of the paired values fall within Zone A. 1. Saugel B, Grothe O, Nicklas JY. Error Grid Analysis for Arterial Pressure Method Comparison Studies. Anesth Analg. 2018 Apr;126(4):1177-1185
次要结局
- Distribution of Paired Systolic Blood Pressure Measurements Across All Error Grid Zones (A-E)(Intraoperative period (measurements taken every 20 minutes during surgery))
- Distribution of Paired Mean Arterial Pressure (MAP) Measurements Across All Error Grid Zones (A-E)(Intraoperative period (measurements taken every 20 minutes during surgery))
- Effect of Antihypertensive Medication Use on the Accuracy of Systolic NIBP Measurements(Intraoperative period (measurements taken every 20 minutes during surgery))
- Effect of Antihypertensive Medication Use on the Accuracy of Mean Arterial Pressure (MAP) NIBP Measurements(Intraoperative period (measurements taken every 20 minutes during surgery))
研究者
Kamil Darcin
Associate professor
Koç University