Monitoring, PhysiologicNCT04996511
Day Case Colectomy: Optimizing Short Stay-surgery.
A study testing PulseOn in people with Monitoring, Physiologic, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial summary
HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Monitoring, Physiologic
- What is being tested?
- PulseOn
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal resection for any pathology
Who cannot join
- Arrhytmias likely to cause problems with HRV measurements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Päijät-Häme Central Hospital
Lahti, 15850
Juha KA Rinne, MD, 0381911 ext. +358, juha.rinne@phhyky.fi
Jyrki AO Kössi, Adjunct Prof, 0381911 ext. +358, jyrki.kossi@phhyky.fi
About this study
HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.
Read the detailed description
Patients scheduled for colorectal surgery are recruited to the study. HRV parameters including e.g. RMSSD are evaluated before and after surgery. The effect of surgery and possible complications associated with it on parameters and relationship with specific adverse effects caused by complications are evaluated.
- Conditions
- Monitoring, Physiologic
- Being tested
- PulseOn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseOnDevice
Also called Faros, Emfit QS
Postoperative HRV measurement
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Surgery Patients | Experimental | Not described Receives: Device: PulseOn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV) change
Reliability of HRV parameters
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Jan 2020
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Monitoring, PhysiologicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Juha KA Rinne, MD, Principal investigator, Päijät Häme Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996511
- Sponsor's protocol ID
- Q021
- Status last verified
- Feb 2026
- First submitted
- 5 May 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miri S, Rinne JKA, Kossi J, Oksala N, Vehkaoja A. Postoperative stress assessment using PPG-based heart rate variability and exploratory ECG analysis in colorectal surgery. Scand J Clin Lab Invest. 2026 Jul 16:1-13. doi: 10.1080/00365513.2026.2703029. Online ahead of print.
PubMed 42461792Rinne 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.
PubMed 35394583
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day Case Colectomy: Optimizing Short Stay-surgery.
- ClinicalTrials.gov ID
- NCT04996511
- Acronym / sponsor ID
- Q021
- Conditions
- Monitoring, Physiologic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.
Detailed description
Patients scheduled for colorectal surgery are recruited to the study. HRV parameters including e.g. RMSSD are evaluated before and after surgery. The effect of surgery and possible complications associated with it on parameters and relationship with specific adverse effects caused by complications are evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Surgery Patients | Experimental | Device: PulseOn |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colorectal resection for any pathology
Key exclusion criteria (1 listed)
- Arrhytmias likely to cause problems with HRV measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PulseOnAlso: Faros, Emfit QSPostoperative HRV measurement | Device | Colorectal Surgery Patients |
Primary outcome
Heart Rate Variability (HRV) change
Time frame: 3 days
Reliability of HRV parameters
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 42461792Miri S, Rinne JKA, Kossi J, Oksala N, Vehkaoja A. Postoperative stress assessment using PPG-based heart rate variability and exploratory ECG analysis in colorectal surgery. Scand J Clin Lab Invest. 2026 Jul 16:1-13. doi: 10.1080/00365513.2026.2703029. Online ahead of print.
- Derived from this study: PubMed 35394583Rinne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juha KA Rinne, MD principal investigator
Päijät Häme Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PulseOn in people with Monitoring, Physiologic, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juha KA Rinne, MD (03 81911 ext. +358, juha.rinne@phhyky.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) change (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04996511, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.