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The Noninvasive Blood Pressure Measurement Effect on the Hypotension

Primary Purpose

Hypotension During Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Blood Pressure Measurement
Sponsored by
Konya City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypotension During Surgery focused on measuring Intraoperative Hypotension, Noninvasive Blood pressure measurement, More frequent time interval

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age > 18 years; ASA Physical Status 3 and 4; Non-cardiac surgery with expected surgery duration ≥ 2 hours; Supine position during the surgery; Regional or general anesthesia; Planned hospital stay time of at least 24 hours. Exclusion Criteria: Patients who confirm to be pregnant and/or nursing mothers; Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s); Has a condition that precludes routine or tight blood pressure management; Mean arterial blood pressure differences between right and left arm ≥ 5 mmHg; Patient who has physically disabled their arms: 5. Emergency surgery.

Sites / Locations

  • Konya City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5 min. BP

2.5 min. BP

Arm Description

Clinicians will carry out randomized treatments in coordination with research staff. The treatments will be: 1) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures.

Clinicians will carry out randomized treatments in coordination with research staff. The treatments will be: 2) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 2.5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures.

Outcomes

Primary Outcome Measures

The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute
For the primary outcome, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute since it has been shown clinically important in previous studies . We will assess this primary outcome in adults having non-cardiac surgery, a 2.5-minute interval of intraoperative blood measurement group compared to the standard 5-minute interval group.

Secondary Outcome Measures

the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute.
For the secondary outcomes, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute, and absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40mmHg, absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP <65, <60, <50, and <40 mmHg, time-weighted average MAP >100, >110, >120, >140mmHg [mmHg], time-weighted cumulative amount of ephedrine indexed to body weight [µg kg-1 min-1], cumulative amount of administered fluids indexed to surgical duration [mL min-1]

Full Information

First Posted
July 27, 2023
Last Updated
August 15, 2023
Sponsor
Konya City Hospital
Collaborators
Bakırkoy Dr. Sadi Konuk Training and Research Hospital, The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05993481
Brief Title
The Noninvasive Blood Pressure Measurement Effect on the Hypotension
Official Title
The Effect of More Frequent Noninvasive Blood Pressure Measurement on the Detection of Intraoperative Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya City Hospital
Collaborators
Bakırkoy Dr. Sadi Konuk Training and Research Hospital, The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition. The aim of the study is determined as the relationship between two different time intervals of measurements and time spent hypotensive under harm thresholds in non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined if more frequent non-invasive blood pressure measurement use decreases postoperative acute kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes pain or nerve injury in the arms or not.
Detailed Description
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition. Intraoperative hypotension can cause an ischemia-reperfusion injury, manifesting as dysfunction of any vital organ. The kidneys and the heart are the most sensitive organs to be affected. Numerous analyses in diverse non-cardiac surgical populations demonstrate clinically meaningful associations between intraoperative hypotension and myocardial injury, acute kidney injury, serious composite complications, and death. The association between hypotension and various complications seems clear. However, hypotension exposure time provokes acute kidney remains unclear. Myocardial injury after non-cardiac surgery manifests as an acute increase in the concentration of cardiac biomarkers and occurs in 11.6% of non-cardiac surgeries. Myocardial injury after non-cardiac surgery is also associated with a hypotension period, even with only small biomarker increases. Ischemia-reperfusion injury due to hypotension may substantially contribute to postoperative myocardial injury. Acute kidney injury (AKI) is defined as creatinine increase and urine output and is well-validated in medical patients. Acute kidney injury reportedly prolongs hospitalization and increases readmissions; it is also associated with increased healthcare costs, sepsis, and mortality. However, most of the data regarding outcomes of acute kidney injury originate from cohorts of hospitalized medical patients, patients admitted to critical care units, or trauma victims. Postoperative kidney injury can increase after surgery because of dehydration or surgical muscle injury. Furthermore, a recent study found a strong relationship between intraoperative hypotension exposure and non-cardiac surgery-related acute kidney injury in patients <60 years of age. However, another study found no independent association between varying ages and postoperative acute kidney injury without evaluating intraoperative hypotension exposure. The definition of intraoperative hypotension is that a mean arterial pressure (MAP) of 65 mm Hg is accepted as a threshold predicting myocardial injury, which is a leading cause of 30-day postoperative mortality. Additionally, the risk of end-organ dysfunction increases with the length of low arterial blood pressure. According to Walsh et al., as little as 1 minute of exposure to MAP <55 mm Hg is associated with myocardial injury, any cardiac complication, and kidney injury after non-cardiac surgery. The American Society of Anesthesiologists (ASA) "Standards for Basic Anesthetic Monitoring" require measurement and evaluation of arterial blood pressure (BP) at least every five minutes except "under extenuating circumstances," but acknowledge that "brief interruptions of continual monitoring may be unavoidable." The standards apply to all patients undergoing anesthetics (general, regional, or monitored anesthesia care). Intraoperative blood pressure can be measured oscillometrically, usually at 5 minutes intervals, or continuously with an arterial catheter. However, when patients are hemodynamically unstable, the non-invasive blood pressure measurement interval of 5 minutes may be insufficient to assess rapidly changing hemodynamics accurately. Subsequently, the provider sometimes inadvertently fails to re-engage the cyclic measurement of cuff blood pressure. This leads to extended periods when hypotension is not measured, thus potentially compromising patient safety. Arterial catheters are generally used to monitor hemodynamic fluctuations for certain complex operations and patients with significant comorbidities. Recent studies even suggest that only a few minutes of hypotension in the acute care setting increases the incidence of complications. These observations strongly suggest that continuous blood pressure monitoring is critical in the acute care setting to identify periods of hypertension and/or hypotension as early as possible. Today, the gold standard for blood pressure monitoring is the invasive arterial line, a catheter inserted into an artery, which enables continuous blood pressure monitoring. On the other hand, it is impossible to place the arterial catheter on all patients because of invasiveness and complications. One extensive study on the topic, in a systematic review, assessed the complications associated with an arterial catheter in >25 000 cases. In this study, temporary artery occlusion was the most frequent complication ranging from 1.5 to 35% (average: 19.7%). Hematomas were the second most common complication, with an incidence of 14.4%. Serious complications such as permanent occlusion, pseudoaneurysm, and sepsis occurred in 0.09%, 0.09%, and 0.13% of cases, respectively. Therefore, the aim of the study will be determined as the relationship between two different time intervals of measurements and time spend hypotensive under harm thresholds in non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined if more frequent non-invasive blood pressure measurement use decreases postoperative acute kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes pain or nerve injury in the arms or not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension During Surgery
Keywords
Intraoperative Hypotension, Noninvasive Blood pressure measurement, More frequent time interval

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 min. BP
Arm Type
Active Comparator
Arm Description
Clinicians will carry out randomized treatments in coordination with research staff. The treatments will be: 1) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures.
Arm Title
2.5 min. BP
Arm Type
Active Comparator
Arm Description
Clinicians will carry out randomized treatments in coordination with research staff. The treatments will be: 2) Ephedrine treatment to maintain intraoperative MAP ≥60 mmHg, delayed resumption of chronic antihypertensive medications as monitoring with 2.5 min. Blood pressure management. The staff anesthesiologist will administer an ephedrine sulfate injection. An initial dose of 5 to 10 mg given as an intravenous bolus is advised for the treatment of clinically significant hypotension during anesthesia to provide an increase in blood pressure in case of MAP< 60 mmHg. However, the dose of each will be titrated as necessary to reach the target mean arterial pressures.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood Pressure Measurement
Intervention Description
NIBP measurements will be recorded intraoperatively every 2.5 minutes for the group of 2.5 min. Blood pressure management or every 5 minutes for the other group of 5 min. Blood pressure management after providing randomization before the surgery. A calibrated and time-matched same type of standard anesthetic monitor will be used. The monitor will measure blood pressure and display the mean, systolic and diastolic values. All blood pressure measurements will be discontinued before the PACU transfer. Data will be automatically downloaded from the monitor to a computer using a software interface program.
Primary Outcome Measure Information:
Title
The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute
Description
For the primary outcome, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute since it has been shown clinically important in previous studies . We will assess this primary outcome in adults having non-cardiac surgery, a 2.5-minute interval of intraoperative blood measurement group compared to the standard 5-minute interval group.
Time Frame
Every 2.5 minute in the surgery upto end of the surgery.
Secondary Outcome Measure Information:
Title
the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute.
Description
For the secondary outcomes, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute, and absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40mmHg, absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP <65, <60, <50, and <40 mmHg, time-weighted average MAP >100, >110, >120, >140mmHg [mmHg], time-weighted cumulative amount of ephedrine indexed to body weight [µg kg-1 min-1], cumulative amount of administered fluids indexed to surgical duration [mL min-1]
Time Frame
Every 2.5 minute in the surgery upto end of the surgery.
Other Pre-specified Outcome Measures:
Title
Postoperative complications after surgery including acute myocardial infarction, acute kidney injury, non-fatal cardiac arrest, peripheral nerve injuries, arm pain and death
Description
The exploratory outcomes will be Postoperative complications after surgery including acute myocardial infarction, acute kidney injury, non-fatal cardiac arrest, peripheral nerve injuries, arm pain and death, a 2.5-minute interval group of intraoperative blood measurement compared to standard 5-minute interval group, 2 hours after surgery in the post-anesthesia recovery unit and after 24 hours.
Time Frame
Postoperative time until 24th hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years; ASA Physical Status 3 and 4; Non-cardiac surgery with expected surgery duration ≥ 2 hours; Supine position during the surgery; Regional or general anesthesia; Planned hospital stay time of at least 24 hours. Exclusion Criteria: Patients who confirm to be pregnant and/or nursing mothers; Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s); Has a condition that precludes routine or tight blood pressure management; Mean arterial blood pressure differences between right and left arm ≥ 5 mmHg; Patient who has physically disabled their arms: 5. Emergency surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasin Tire, Assoc. Prof.
Phone
+905055367970
Email
dryasintire@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gökhan Sertçakacılar, Assoc. Prof.
Phone
+905053130818
Email
gokhansertcakacilar@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasin Tire, Assoc. Prof.
Organizational Affiliation
Konya City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konya City Hospital
City
Konya
State/Province
Meram
ZIP/Postal Code
42140
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasin Tire
Phone
05055367970
Email
dryasintire@hotmail.com

12. IPD Sharing Statement

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The Noninvasive Blood Pressure Measurement Effect on the Hypotension

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