Continuous Versus 1-min Oscillometric Arterial BP Monitoring

NCT05792436 | Completed

• 1 other identifier: SPROUT-2
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia, General

Keywords

Intraoperative hypotention; Induction of anesthesia; Arterial blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Area under MAP of 60, 50, 40 mmHg (mmHg∙min)

  From the start of anesthesia induction to 15 minutes after

• Duration of MAP <65, <60, <50, <40 mmHg (min)

  From the start of anesthesia induction to 15 minutes after

• Exposure to MAP <65, <60, <50, and <40 mmHg (binary)

  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)

  From the start of anesthesia induction to 15 minutes after

• Area above MBP of 100, 110, 120, 140 mmHg (mmHg∙min)

  From the start of anesthesia induction to 15 minutes after

Study Arms (2)

1-min interval oscillometric method

EXPERIMENTAL

1-min interval blood pressure monitoring using oscillometric method during induction of anesthesia

Device: 1-min interval oscillometric method

arterial catheterization method

ACTIVE COMPARATOR

Continuous blood pressure monitoring through arterial catheter during induction of anesthesia

Device: arterial catheterization method

Interventions

1-min interval oscillometric method DEVICE

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.

1-min interval oscillometric method

arterial catheterization method DEVICE

During the same time window for 1-min interval oscillometric method, arterial blood pressure is monitored using continuous blood pressure monitoring.

arterial catheterization method

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Study Officials

• Karam Nam, MD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: March 31, 2023
• Study Start: April 27, 2023
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

KR (2)