How Accurate Is Non-Invasive Blood Pressure Monitoring During Trendelenburg Laparoscopic Surgery?
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKoç University
About this trial
This study will test how accurate a blood pressure cuff is during certain types of surgery.
During some abdominal surgeries done with small tools and a camera (called laparoscopic surgery), doctors place patients in a head-down position called the Trendelenburg position. In this position, it may be harder for the blood pressure cuff on the arm to give correct readings. This study will compare the cuff's readings (non-invasive) with readings from a thin tube placed inside an artery (invasive), which is more accurate but also more risky and uncomfortable.
The researchers will use a method called error grid analysis to check how closely the cuff readings match the invasive ones. They hope to learn if the blood pressure cuff is accurate enough to be used safely in this kind of surgery. If it is, doctors may not need to use the invasive method as often.
People 18 years or older who are already going to have invasive blood pressure monitoring as part of their planned surgery can join the study. The study will collect blood pressure measurements about every 20 minutes during surgery, as well as basic information like age, weight, and what medicines are given.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Scheduled to undergo laparoscopic surgery in the Trendelenburg position
Will receive invasive arterial blood pressure monitoring as part of routine clinical care
Disqualifiers
Has peripheral artery disease
Has congestive heart failure
Trial population
Participants will be selected from adult patients scheduled for laparoscopic surgery in the Trendelenburg position at Koç University Hospital, a tertiary care academic medical center in Istanbul, Turkey.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Surgical Cohort
Trial outcomes
Primary outcomes
1
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
Time frame
Intraoperative period (measurements taken every 20 minutes during surgery)2
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
Time frame
Intraoperative period (measurements taken every 20 minutes during surgery)Secondary outcomes
1
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.
Time frame
Intraoperative period (measurements taken every 20 minutes during surgery)2
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.
Time frame
Intraoperative period (measurements taken every 20 minutes during surgery)3
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.
Time frame
Intraoperative period (measurements taken every 20 minutes during surgery)4
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.
Time frame
Intraoperative period (measurements taken every 20 minutes during surgery)Sponsors and contacts
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Source ClinicalTrials.gov
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