Continuous Versus 1-min Oscillometric Arterial BP Monitoring

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05792436
Collaborator
(none)
244
2
2
13
122
9.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 1-min interval oscillometric method
  • Device: arterial catheterization method
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Continuous Invasive Versus 1-min Interval Oscillometric Arterial Pressure Monitoring and Hypotension During Induction of Anesthesia: a Bicenter, Randomized, Noninferiority Trial
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. MAP integral [From the start of anesthesia induction to 15 minutes after]

    The area under the mean arterial pressure (MAP) of 65 mmHg calculated using the MAP recorded every second

Secondary Outcome Measures

  1. Area under MAP of 60, 50, 40 mmHg (mmHg∙min) [From the start of anesthesia induction to 15 minutes after]

    calculated using the MAP recorded every second

  2. Duration of MAP <65, <60, <50, <40 mmHg (min) [From the start of anesthesia induction to 15 minutes after]

    calculated using the MAP recorded every second

  3. Exposure to MAP <65, <60, <50, and <40 mmHg (binary) [From the start of anesthesia induction to 15 minutes after]

    calculated using the MAP recorded every second

  4. 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]

    calculated using the MAP recorded every second

  5. Area above MBP of 100, 110, 120, 140 mmHg (mmHg∙min) [From the start of anesthesia induction to 15 minutes after]

    calculated using the MAP recorded every second

  6. MAP standard deviation (mmHg) [From the start of anesthesia induction to 15 minutes after]

    calculated using the MAP recorded every second

  7. Use of vasopressor (binary) [From the start of anesthesia induction to 15 minutes after]

    ephedrine, phenylephrine, norepinephrine (binary)

  8. Use of vasopressor (dose) [From the start of anesthesia induction to 15 minutes after]

    ephedrine (mg), phenylephrine (μg/kg), norepinephrine (μg/kg)

  9. Crystalloid (ml) [From the start of anesthesia induction to 15 minutes after]

    Total amount of crystalloid administered

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080
2 Korea University Guro Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karam Nam, MD, Clinical Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05792436
Other Study ID Numbers:
  • 2302-111-1407
First Posted:
Mar 31, 2023
Last Update Posted:
Mar 31, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karam Nam, MD, Clinical Associate Professor, Seoul National University Hospital

Study Results

No Results Posted as of Mar 31, 2023