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

NCT04736862 | Completed

• 1 other identifier: PV7361
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Perioperative Hypotension

Outcome Measures

Primary Outcomes (2)

• Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.

  15 min

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

  intraoperative

Study Arms (2)

Continuous monitoring group

EXPERIMENTAL

Device: Continuous non-invasive blood pressure monitoring

Intermittent monitoring group

ACTIVE COMPARATOR

Device: Intermittent non-invasive blood pressure monitoring

Interventions

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.

Continuous monitoring group

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.

Intermittent monitoring group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, 20246, Germany

Location

Related Publications (1)

• Kouz K, Weidemann F, Naebian A, Lohr A, Bergholz A, Thomsen KK, Krause L, Petzoldt M, Moll-Khosrawi P, Sessler DI, Flick M, Saugel B. Continuous Finger-cuff versus Intermittent Oscillometric Arterial Pressure Monitoring and Hypotension during Induction of Anesthesia and Noncardiac Surgery: The DETECT Randomized Trial. Anesthesiology. 2023 Sep 1;139(3):298-308. doi: 10.1097/ALN.0000000000004629.

  PMID: 37265355 DERIVED

Study Officials

• Karim Kouz, M.D.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 3, 2021
• Study Start: March 23, 2021
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)