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Completed

NCT Number: NCT04736862

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

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.

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Key information

Conditions

Blood Pressure Perioperative Hypotension

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, 20246, Germany

About this study

not provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous non-invasive blood pressure monitoring

Device

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.

Intermittent non-invasive blood pressure monitoring

Device

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 outcomes

  1. 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

  2. Time-weighted average for MAP <65 mmHg during the intraoperative period between the intervention and the control group.

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2021
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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