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NCT Number: NCT06753097

Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial

This is a randomized trial (1) investigating whether continuous finger-cuff - compared to intermittent oscillometric - arterial pressure monitoring reduces the amount of intraoperative hypotension (specifically, from the start of induction of general anesthesia until the end of surgery) in low-to-moderate risk patients having elective non-cardiac surgery.

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Key information

Conditions

Intraoperative Hypotension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

About this study

not provided

Who can participate

Healthy volunteers accepted: No

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

We will include three types of patients:

  • Patients scheduled for ambulatory (outpatient) elective non-cardiac surgery expected to last ≥30 minutes
  • Low-risk patients (ASA I+II) having inpatient elective non-cardiac surgery expected to last ≥60 minutes
  • Moderate-risk patients (ASA III) having inpatient elective non-cardiac surgery expected to last ≥60 minutes

We will only include patients who are 18 years or older; who will have general anesthesia; and in whom intermittent arterial pressure monitoring with upper-arm cuff oscillometry is planned.

Patients that meet one or more of the following exclusion criteria cannot participate in the trial:

  • Emergency surgery
  • Patients on renal replacement therapy
  • Contraindications for finger-cuff monitoring (e.g., Raynaud disease)

Treatment and study plan

Continuous finger-cuff arterial pressure monitoring

Device

Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring.

Primary outcomes

  1. Time-weighted average mean arterial pressure <65 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

Secondary outcomes

  1. Time-weighted average mean arterial pressure <60 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  2. Time-weighted average mean arterial pressure <50 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  3. Time-weighted average mean arterial pressure <40 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  4. Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <65 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  5. Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <60 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  6. Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <50 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  7. Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <40 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  8. Cumulative duration of a mean arterial pressure <65 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  9. Time-weighted average mean arterial pressure >100 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  10. Time-weighted average mean arterial pressure >110 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  11. Time-weighted average mean arterial pressure >120 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

  12. Time-weighted average mean arterial pressure >140 mmHg

    Time frame: during the start of induction of general anesthesia until the end of surgery

Other outcomes

  1. Acute kidney injury

    Time frame: Up until the first postoperative day

    Acute kidney injury (binary outcome) will be defined as an increase in postoperative serum creatinine from baseline of at least 0.3 mg/dl or ≥50%.

  2. Acute myocardial injury

    Time frame: Up until the first postoperative day

    Acute myocardial injury (binary outcome) will be defined based on the definition of "myocardial injury and infarction associated with non-cardiac procedures" according to the Fourth Universal Definition of Myocardial Infarction (2018)

  3. Time-weighted average of the percentage decrease in regional cerebral oxygen saturation from the baseline

    Time frame: during the start of induction of general anesthesia until the end of surgery

  4. Incidence of cerebral hypoxia

    Time frame: during the start of induction of general anesthesia until the end of surgery

    Cerebral hypoxia will be defined as a regional cerebral oxygen saturation (rcSO2) <50% or a decrease in rcSO2 >20% from baseline (if the baseline was ≥50%) or a decrease in rcSO2 >15% from baseline (if the baseline was <50%).

  5. Cumulative duration of cerebral hypoxia

    Time frame: during the start of induction of general anesthesia until the end of surgery

    Cerebral hypoxia will be defined as a regional cerebral oxygen saturation (rcSO2) <50% or a decrease in rcSO2 >20% from baseline (if the baseline was ≥50%) or a decrease in rcSO2 >15% from baseline (if the baseline was <50%).

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: DETECT II

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Mar 9, 2026

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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