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.
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
Has peripheral artery disease
Has congestive heart failure
Participants will be selected from adult patients scheduled for video-assisted thoracoscopic surgery with one-lung ventilation at Koç University Hospital, a tertiary care academic medical center in Istanbul, Turkey.
Cohort
Prospective
Not listed
Proportion of Paired Systolic Blood Pressure Measurements Within Zone A of the Error Grid
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
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
Distribution of Paired Systolic Blood Pressure Measurements Across All Error Grid Zones (A-E)
The percentage of paired systolic blood pressure measurements that fall into each zone (A, B, C, D, E) of the consensus error grid. Error grid zones reflect the clinical risk of acting on the non-invasive measurement: Zone A: No risk Zone B: Low risk Zone C: Moderate risk Zone D: Significant risk of undertreatment Zone E: Significant risk of overtreatment The distribution will be reported as the percentage of all paired measurements falling into each zone.
Distribution of Paired Mean Arterial Pressure (MAP) Measurements Across All Error Grid Zones (A-E)
The percentage of paired mean arterial pressure (MAP) measurements that fall into each zone (A through E) of the consensus error grid. Error grid zones reflect the clinical risk of acting on the non-invasive measurement: Zone A: No risk Zone B: Low risk Zone C: Moderate risk Zone D: Significant risk of undertreatment Zone E: Significant risk of overtreatment The distribution will be reported as the percentage of all paired measurements falling into each zone.
Effect of Antihypertensive Medication Use on the Accuracy of Systolic NIBP Measurements
This outcome compares the likelihood that individual systolic non-invasive blood pressure (NIBP) measurements fall within Zone A of the consensus error grid between participants who use antihypertensive medications and those who do not. Zone A indicates values that would not lead to inappropriate clinical decisions. To account for the fact that multiple blood pressure measurements are collected from each participant, the analysis will use mixed-effects logistic regression. This model includes a random effect for each participant to account for the correlation among repeated measurements within the same individual.
Effect of Antihypertensive Medication Use on the Accuracy of Mean Arterial Pressure (MAP) NIBP Measurements
This outcome compares the likelihood that individual non-invasive mean arterial pressure (MAP) measurements fall within Zone A of the consensus error grid between participants with and without antihypertensive medication use. Zone A represents measurement pairs that are clinically acceptable. To account for the fact that multiple blood pressure measurements are collected from each participant, the analysis will use mixed-effects logistic regression. This model includes a random effect for each participant to account for the correlation among repeated measurements within the same individual.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
