NCT06973044

Brief Summary

Is heart rate and respiratory rate measured continuously with a new wireless sensor better as compared to standard care, with manually measured spot checks by nurses on general wards? Does continuous monitoring detect more abnormal respiratory- and heart rate? Are abnormal values associated with increased lenght of stay?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
Last Updated

May 15, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

May 7, 2025

Last Update Submit

May 7, 2025

Conditions

Perioperative ComplicationPerioperative/Postoperative ComplicationsSurgery-Complications

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Time from index surgery to hospital discharge

    Within 60 days of index surgery

Secondary Outcomes (2)

  • Frequency of monitoring

    Within 60 days of index surgery

  • Abnormal respiratory rate and abnormal heart rate

    Within 60 days of index surgery

Interventions

Checkpoint Cardio wireless continuous monitoring deviceDEVICE

Continuous monitoring of respiratory rate and heart rate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgical high-risk patients, treated at Karolinska University Hospital and UMC Utrecht

You may qualify if:

  • ≥ 18 years of age
  • planned to go through a major high-risk surgery
  • American Society of Anesthesiologists (ASA) class 2-4 due to present comorbidities
  • planned to stay in the postoperative high dependency unit for \>12hours where they also would have wired continuous monitoring.

You may not qualify if:

  • pregnancy
  • presence of implantable defibrillator or pacemaker
  • allergy to skin adhesives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, senior lecturer, associate professor

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 15, 2025

Study Start

November 1, 2020

Primary Completion

September 30, 2021

Study Completion

December 31, 2024

Last Updated

May 15, 2025

Record last verified: 2025-03

Locations

SE(2)