NCT04996511

Brief Summary

HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress79%
Jan 2020Dec 2027

Study Start

First participant enrolled

January 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 22, 2026

Status Verified

February 1, 2026

Enrollment Period

7.4 years

First QC Date

May 5, 2021

Last Update Submit

April 21, 2026

Conditions

Monitoring, Physiologic

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability (HRV) change

    Reliability of HRV parameters

    3 days

Study Arms (1)

Colorectal Surgery Patients

EXPERIMENTAL
Device: PulseOn

Interventions

PulseOnDEVICE

Postoperative HRV measurement

Also known as: Faros, Emfit QS
Colorectal Surgery Patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal resection for any pathology

You may not qualify if:

  • Arrhytmias likely to cause problems with HRV measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Päijät-Häme Central Hospital

Lahti, 15850, Finland

RECRUITING

Related Publications (1)

  • Rinne JKA, Miri S, Oksala N, Vehkaoja A, Kossi J. Evaluation of a wrist-worn photoplethysmography monitor for heart rate variability estimation in patients recovering from laparoscopic colon resection. J Clin Monit Comput. 2023 Feb;37(1):45-53. doi: 10.1007/s10877-022-00854-w. Epub 2022 Apr 8.

    PMID: 35394583DERIVED

Study Officials

  • Juha KA Rinne, MD

    Päijät Häme Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juha KA Rinne, MD

CONTACT

03 81911juha.rinne@phhyky.fi

Jyrki AO Kössi, Adjunct.Prof

CONTACT

03 81911jyrki.kossi@phhyky.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

August 9, 2021

Study Start

January 1, 2020

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 22, 2026

Record last verified: 2026-02

Locations

FI(1)