Continuous Versus 1-min Oscillometric Arterial BP Monitoring

Continuous Invasive Versus 1-min Interval Oscillometric Arterial Pressure Monitoring and Hypotension During Induction of Anesthesia: a Bicenter, Randomized, Noninferiority Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, General
• Intervention / Treatment: Device: 1-min interval oscillometric method; Device: arterial catheterization method

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karam Nam, MD; Phone Number: 82-2-2072-0643; Email: karamnam@gmail.com
• Study Contact Backup: Name: Jae-Woo Ju, MD; Phone Number: 82-2-2072-2467; Email: jujw701@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Karam Nam, M.D.; Phone Number: 82-02-2072-0643; Email: karamnam@gmail.com
    • Contact: Jae-Woo Ju, M.D.; Phone Number: 82-02-2072-2469; Email: jujw701@gmail.com
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Korea University Guro Hospital
    • Contact: Hye-Bin Kim, M.D.; Email: aneshbkim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1-min interval oscillometric method; 1-min interval blood pressure monitoring using oscillometric method during induction of anesthesia	Device: 1-min interval oscillometric method; Before induction of anesthesia, 20-gauge catheter is inserted to radial artery after local anesthesia with lidocaine, and continuous blood pressure monitoring is started. Anesthesia is induced using propofol, opioids (fentanyl or remifentanil), and neuromuscular relaxants (rocuronium, cisatracurium, or vecuronium). For maintenance of anesthesia, propofol infusion or inhalation anesthetics (sevoflurane or desflurane) are used. From the start of anesthesia induction to 15 minutes after, arterial blood pressure is monitored at 1-min interval using oscillometric method. The display of continuous arterial pressure on the anesthesia monitor is turned off during the 15-min study period.
Active Comparator: arterial catheterization method; Continuous blood pressure monitoring through arterial catheter during induction of anesthesia	Device: arterial catheterization method; During the same time window for 1-min interval oscillometric method, arterial blood pressure is monitored using continuous blood pressure monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAP integral	The area under the mean arterial pressure (MAP) of 65 mmHg calculated using the MAP recorded every second	From the start of anesthesia induction to 15 minutes after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under MAP of 60, 50, 40 mmHg (mmHg∙min)	calculated using the MAP recorded every second	From the start of anesthesia induction to 15 minutes after
Duration of MAP <65, <60, <50, <40 mmHg (min)	calculated using the MAP recorded every second	From the start of anesthesia induction to 15 minutes after
Exposure to MAP <65, <60, <50, and <40 mmHg (binary)	calculated using the MAP recorded every second	From the start of anesthesia induction to 15 minutes after
Exposure to continuous MAP <65, <60, <50, <40 mmHg for 1 minute or longer (binary)	calculated using the MAP recorded every second	From the start of anesthesia induction to 15 minutes after
Area above MBP of 100, 110, 120, 140 mmHg (mmHg∙min)	calculated using the MAP recorded every second	From the start of anesthesia induction to 15 minutes after
MAP standard deviation (mmHg)	calculated using the MAP recorded every second	From the start of anesthesia induction to 15 minutes after
Use of vasopressor (binary)	ephedrine, phenylephrine, norepinephrine (binary)	From the start of anesthesia induction to 15 minutes after
Use of vasopressor (dose)	ephedrine (mg), phenylephrine (μg/kg), norepinephrine (μg/kg)	From the start of anesthesia induction to 15 minutes after
Crystalloid (ml)	Total amount of crystalloid administered	From the start of anesthesia induction to 15 minutes after

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Karam Nam, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Induction of anesthesia; Intraoperative hypotention; Arterial blood pressure monitoring
• Other Study ID Numbers: SPROUT-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No