Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery

NCT07385092 | Recruiting

• 1 other identifier: 2023-101178-BO-ff
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

The "COME ON, NOW!" trial is a randomized, single-center trial in patients recovering from non-cardiac surgery on normal wards investigating whether continuous vital sign monitoring - compared to routine spot-checks by nurses - reduces the total duration of abnormal vital signs per hour during the first 48 hours after admission to the normal ward.

Conditions

Vital Sign Monitoring; Post Operative Complications; Non-cardiac Surgery; RCT; Anesthesiology

Keywords

continuous vital signs; vital signs; vital sign monitoring; post-operative care; anesthesiology; anesthesia; hypotension; post-operative complications

Outcome Measures

Primary Outcomes (1)

• Total duration of abnormal vital signs

  Total duration of abnormal vital signs per hour (minutes per hour) during the first 48 hours after admission to the normal ward, i.e., the minutes per hour patients have any of the following abnormal vital signs ("any versus none"): peripheral oxygen saturation (SpO2) \<85%, mean arterial pressure (MAP) \<60 mmHg, heart rate \<45 bpm or \>130 bpm, and respiratory rate \<7/min or \>30/min.

  48 hours after admission to the normal ward

Secondary Outcomes (37)

• Individual components of the composite primary endpoint

  48 hours after admission to the normal ward

• Individual components of the composite primary endpoint

  48 hours after admission to the normal ward

• Individual components of the composite primary endpoint

  48 hours after admission to the normal ward

• Individual components of the composite primary endpoint

  48 hours after admission to the normal ward

• Individual components of the composite primary endpoint

  48 hours after admission to the normal ward

Other Outcomes (2)

• Composite of serious in-hospital complications

  48 hours after admission to the normal ward

• Time-to-event endpoint

  30 days after index surgery

Study Arms (2)

Blinded continuous vital sign monitoring

SHAM COMPARATOR

Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.

Device: Blinded continuous vital sign monitoring

Unblinded continuous vital sign monitoring

EXPERIMENTAL

Continuous ward monitoring with vital signs available to investigators.

Device: Unblinded continuous vital sign monitoring

Interventions

Unblinded continuous vital sign monitoring DEVICE

Continuous ward monitoring with vital signs available to investigators. Oxygen saturation, blood pressure (intermittent in intervals of 60 minutes), heart rate, and respiratory rate will be continuously measured and streamed to the investigators (specifically, to a central monitor). The investigators will alert nurses or physicians when SpO2 is \<85% for ≥2 minutes, respiratory rate is \<7/min or \>30/min for ≥2 minutes, MAP is \<60 mmHg, or heart rate is \<45 bpm or \>130 bpm for ≥2 minutes, or in case of apnea for ≥1 minute - supplemented by clinical judgement and the complete electronic record. Investigators will alert clinicians when concerning patterns are identified, whether or not alerts have been triggered. Clinicians will determine if response is necessary and what interventions might be appropriate.

Unblinded continuous vital sign monitoring

Blinded continuous vital sign monitoring DEVICE

Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.

Blinded continuous vital sign monitoring

Eligibility Criteria

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

You may qualify if:

• Consenting patients ≥45 years scheduled for elective non-cardiac (abdominal and thoracic) surgery with planned postoperative admission to a normal ward after an overnight stay in an advanced post-anesthesia care unit.

You may not qualify if:

• Emergency surgery
• Pregnancy
• Impossibility to perform continuous monitoring with the Radius VSM sensor (Masimo, Irvine, CA)
• Atrial fibrillation
• Patients designated Do Not Resuscitate, or are receiving end-of-life care

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20251, Germany

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bernd Saugel, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen K Thomsen, MD

CONTACT

+4940741070215; kr.thomsen@uke.de

Simon Stemmler, MD

CONTACT

+4940741066077; s.stemmler@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to group allocation. Clinicians and investigators will be blinded to continuous vital signs in the control group. In the intervention group, clinicians will receive information on vital signs from the study staff. Data analysts are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 3, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)