Continuous Versus 1-min Oscillometric Arterial BP Monitoring

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792436
• Other study ID #: SPROUT-2
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Seoul National University Hospital
• Contact: Karam Nam, MD
• Phone: 82-2-2072-0643
• Email: karamnam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	MAP standard deviation (mmHg)	calculated using the MAP recorded every second	From the start of anesthesia induction to 15 minutes after
Secondary	Use of vasopressor (binary)	ephedrine, phenylephrine, norepinephrine (binary)	From the start of anesthesia induction to 15 minutes after
Secondary	Use of vasopressor (dose)	ephedrine (mg), phenylephrine (µg/kg), norepinephrine (µg/kg)	From the start of anesthesia induction to 15 minutes after
Secondary	Crystalloid (ml)	Total amount of crystalloid administered	From the start of anesthesia induction to 15 minutes after