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Impact of Continuous Non-invasive Blood Pressure Monitoring on Hypotension in Patients Having Non-cardiac Surgery

Primary Purpose

Blood Pressure, Perioperative Hypotension

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Continuous non-invasive blood pressure monitoring
Intermittent non-invasive blood pressure monitoring
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients at least 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned.

Exclusion Criteria:

  • Emergency surgery,
  • pregnancy,
  • American Society of Anesthesiologists (ASA) physical status classification V or VI, blood pressure differences between the right and left arm of more than 20 mmHg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.

Sites / Locations

  • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous monitoring group

Intermittent monitoring group

Arm Description

Outcomes

Primary Outcome Measures

Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.
Time-weighted average for MAP <65 mmHg during the intraoperative period between the intervention and the control group.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2021
Last Updated
October 11, 2021
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT04736862
Brief Title
Impact of Continuous Non-invasive Blood Pressure Monitoring on Hypotension in Patients Having Non-cardiac Surgery
Official Title
The Impact of Continuous Non-invasive Blood Pressure Monitoring on Post-induction and Intraoperative Hypotension in Patients Having Non-cardiac Surgery (DETECT Trial): A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
October 6, 2021 (Actual)
Study Completion Date
October 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

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

5. Study Description

Brief Summary
This is a randomized trial (1) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery; and (2) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the time-weighted average for MAP <65 mmHg during the intraoperative period compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery.
Detailed Description
not provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Perioperative Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous monitoring group
Arm Type
Experimental
Arm Title
Intermittent monitoring group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Continuous non-invasive blood pressure monitoring
Intervention Description
In patients randomized to the continuous monitoring group, continuous non-invasive finger-cuff blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist will be blinded to intermittent blood pressure monitoring using upper-arm cuff oscillometry.
Intervention Type
Device
Intervention Name(s)
Intermittent non-invasive blood pressure monitoring
Intervention Description
In patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring using upper-arm cuff oscillometry will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous non-invasive finger-cuff blood pressure monitoring.
Primary Outcome Measure Information:
Title
Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.
Time Frame
15 min
Title
Time-weighted average for MAP <65 mmHg during the intraoperative period between the intervention and the control group.
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients at least 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned. Exclusion Criteria: Emergency surgery, pregnancy, American Society of Anesthesiologists (ASA) physical status classification V or VI, blood pressure differences between the right and left arm of more than 20 mmHg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Kouz, M.D.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Continuous Non-invasive Blood Pressure Monitoring on Hypotension in Patients Having Non-cardiac Surgery

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