Prospective Validation of Intraoperative Blood Pressure Monitors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
This observational study aims to identify the incidence and importance of discrepancies between measurements of intraoperative invasive and noninvasive blood pressure monitoring in patients undergoing non-cardiac surgeries under general anesthesia . The main questions it aims to answer are :
* The importance of the differences, in mmHg, between the non-invasive and invasive blood pressure measurements (NIBP-IBP) on systolic, diastolic and mean arterial pressure. * Identify the predictive factors associated with these differences.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully consented, adult patients above 18 years old;
Undergoing surgery of duration time expected at least 60 minutes using general anesthesia;
Supine positioning during the surgery;
Surgery requiring an arterial line;
Disqualifiers
Atrial fibrillation, multifocal atrial tachycardia, or any other irregular hear rythm;
Gradient of mean arterial pressure between the two arms greater than 5 mm Hg, as measured during the recruitment process.
Trial population
Adult patients undergoing non-cardiac elective surgery expected to last at least 60 minutes, under general anesthesia, and to require an arterial line.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Difference between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements
Describe the difference, in mm of Hg, between intraoperative monitoring of noninvasive and invasive blood (NIBP-IBP) on systolic, diastolic and mean arterial pressures
Time frame
Time Frame: from arrival in preoperative unit patient's departure from PACU and/or removal of IBP device, expected duration approximately between 2 and 8 hours2
Predictive factors associated with the between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurement differences
Identify predictive factors (such as patient, surgery, and anesthesia characteristics) statistically associated with the appearance of NIBP-IBP measurement differences
Time frame
Time Frame: From patient file analysis at time of recruitment until patient's departure from PACU and/or removal of IBP device, expected duration approximately a year.Secondary outcomes
1
Comparison of preoperative NIBP and pre-induction NIBP
Compare preoperative non-invasive blood pressure (NIBP) measurements prior to the surgery and the average pre-induction NIBP recorded in the operating room
Time frame
From installation of non-invasive blood pressure (NIBP) device in preop until installation of arterial line, pre-induction. Expected duration approximately between 1 and 2 hours.2
Compare the discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements to the accuracy standards of the Association for the Advancement of Medical Instrumentation
Compare the NIBP-IBP discrepancy to the accuracy standards of the Association for the Advancement of Medical Instrumentation (AAMI): a maximal mean difference of 5 mm Hg and a standard deviation of 8 mm Hg.
Time frame
From installation of patient's arterial line until removal of patient's arterial line, expected duration approximately between 1 and 8 hours.3
Impact of patient comorbidities (age, weight, height, BMI, heart condition, vascular condition) on occurrences of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements
Evaluate the impact of patient's characteristics and comorbidities collected via REDCap questionnaire (age, weight, height, BMI, heart condition, vascular condition) on the occurrence of NIBP-IBP discrepancies.
Time frame
From patient file analysis at time of recruitment until the end of statistical analysis. Expected duration: up to a year.4
Statistical correlation between radial artery ultrasound measurements on the occurrence of discrepancies between non-invasive blood pressure (NIBP) and invasive blood pressure (IBP) measurements
Evaluate the impact, via statistical analysis, of radial artery ultrasound characteristics (inter-intima diameter, velocity) on the occurrence of NIBP-IBP discrepancies.
Time frame
From measurement of patient's radial artery via ultrasonography before induction until the end of statistical analysis. Expected duration: up to a year.Sponsors and contacts
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Source ClinicalTrials.gov
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