Clinical trial NCT05792436: Continuous Versus 1-min Oscillometric Arterial BP Monitoring
Official title: Continuous Invasive Versus 1-min Interval Oscillometric Arterial Pressure Monitoring and Hypotension During Induction of Anesthesia: a Bicenter, Randomized, Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia, General
Keywords: Intraoperative hypotention
Induction of anesthesia
Arterial blood pressure monitoring
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 258
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypotension is common during surgery and about one-third of hypotension occur during the period from anesthesia induction to skin incision. Therefore, monitoring blood pressure during this period is crucial.

Two methods are used for measuring blood pressure during surgery: the intermittent measurement method (oscillometric method) and the continuous measurement method (arterial catheterization method). The latter is frequently used in surgical patients who require meticulous hemodynamic management, although there is no clearly defined indication for its use. Despite the benefits of arterial catheterization, it is often delayed after induction of general anesthesia, and blood pressure is monitored intermittently using the oscillometric method.

A recent study showed that continuous arterial pressure monitoring using arterial catheterization method during the induction of general anesthesia reduced hypotension significantly compared to 2.5-min interval intermittent arterial pressure monitoring using oscillometric method. The study was conducted on patients scheduled for continuous arterial pressure monitoring during surgery and the group with continuous arterial pressure monitoring showed significantly lower incidence of hypotension during the first 15 minutes of anesthesia induction.

However, measuring blood pressure using the oscillometric method at 1-min interval, rather than 2.5-min interval, may not be significantly inferior to continuous monitoring via arterial catheterization in terms of hypotension occurrence. This study aims to compare hypotension incidence between arterial catheterization method and oscillometric method with 1-min interval during induction of anesthesia in non-cardiac surgery patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 19 or older undergoing scheduled non-cardiac surgery with general anesthesia and continuous invasive arterial blood pressure monitoring via the radial artery

Exclusion Criteria:

* Arterial access is clinically necessary before induction of anesthesia (e.g., moderate or higher degree of aortic stenosis, moderate or higher degree of heart failure, coronary artery disease requiring revascularization, intracranial aneurysm with a significant risk of rupture, etc.)
* Emergency surgery
* American Society of Anesthesiologists (ASA) physical status 5 or 6
* Arterial access is required in a different artery other than the radial artery (e.g., the femoral artery)
* Electrocardiogram other than sinus rhythm
* Refusal to participate in the study

Primary outcomes:
measure: MAP integral
timeFrame: From the start of anesthesia induction to 15 minutes after
Secondary outcomes:
measure: Area under MAP of 60, 50, 40 mmHg (mmHg∙min)
timeFrame: From the start of anesthesia induction to 15 minutes after
measure: Duration of MAP <65, <60, <50, <40 mmHg (min)
timeFrame: From the start of anesthesia induction to 15 minutes after
measure: Exposure to MAP <65, <60, <50, and <40 mmHg (binary)
timeFrame: From the start of anesthesia induction to 15 minutes after
measure: Exposure to continuous MAP <65, <60, <50, <40 mmHg for 1 minute or longer (binary)
timeFrame: From the start of anesthesia induction to 15 minutes after
measure: Area above MBP of 100, 110, 120, 140 mmHg (mmHg∙min)
timeFrame: From the start of anesthesia induction to 15 minutes after
measure: MAP standard deviation (mmHg)
timeFrame: From the start of anesthesia induction to 15 minutes after
measure: Use of vasopressor (binary)
timeFrame: From the start of anesthesia induction to 15 minutes after
measure: Use of vasopressor (dose)
timeFrame: From the start of anesthesia induction to 15 minutes after
measure: Crystalloid (ml)
timeFrame: From the start of anesthesia induction to 15 minutes after
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Karam Nam, MD
role: STUDY_DIRECTOR
References: