Perioperative ComplicationCIM-LOSNCT06973044
Continuous vs Intermittent Monitoring of Respiratory and Heart Rate in Relation to Length of Stay
An observational study of Perioperative Complication and Perioperative/Postoperative Complications, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication, Perioperative/Postoperative Complications, Surgery-Complications
- What is being tested?
- Checkpoint Cardio wireless continuous monitoring device
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Nov 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical high-risk patients, treated at Karolinska University Hospital and UMC Utrecht
Who may be able to join
- ≥ 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.
Who cannot join
- pregnancy
- presence of implantable defibrillator or pacemaker
- allergy to skin adhesives
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska University Hospital
Stockholm, 171 76
Karolinska Institutet
Stockholm
About this study
Official title: Comparison Between Continuous and Intermittent Monitoring of Abnormal Respiratory and Heart Rate in Relation to Length of Stay. A Clinical Multicenter Study of Continuous Wireless Monitoring Within the NIGHTINGALE Project
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?
Read the detailed description
Tachypnea is not just a sign of ventilatory problems with hypoxia, but also a precursor of sepsis, metabolic acidosis and severe pain reflecting its role as an indicator of severe derangement in many body systems. A high respiratory rate has been shown to be the most reliable vital sign to predict clinical deterioration, cardiac arrest and is even associated with higher mortality rates. Despite this, it is the vital parameter most neglected; poorly documented or not recorded at all. Studies have shown that respiratory rate is measured in less than half of cases consequently jeopardizing patient safety. The lack of understanding why respiratory rate is important and its superiority to pulse oximetry in predicting clinical deterioration may be one of the reasons why it is not measured accurately.
Badawy and colleagues stated in their study "Is everyone really breathing 20 times a minute?" that respiratory rate was inaccurately recorded and had little variation in the recordings, even in patients with cardiopulmonary compromise, findings that's been supported with later studies. Respiratory rate has traditionally not been objectively measured in general wards, but instead calculated manually over 30 seconds or a minute. This could be changed by new wireless monitoring technology. A recent large study showed that continuous measured respiratory rate together with heart rate and age in a clinical deterioration model outperformed traditional early warning scores in predicting ICU admission.
The present study evaluates heart rate and respiratory rate measured continuously with a new wireless sensor as compared to standard care, with manually measured spot checks by nurses on general wards.
- Conditions
- Perioperative Complication, Perioperative/Postoperative Complications, Surgery-Complications
- Being tested
- Checkpoint Cardio wireless continuous monitoring device
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checkpoint Cardio wireless continuous monitoring deviceDevice
Continuous monitoring of respiratory rate and heart rate
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Time from index surgery to hospital discharge
Measured: Within 60 days of index surgery
Secondary outcomes (2)
Frequency of monitoring
Time spent on continuous and intermittent monitoring
Measured: Within 60 days of index surgery
Abnormal respiratory rate and abnormal heart rate
Time spent in predefined abnormal RR and HR, with continuous and intermittent monitoring
Measured: Within 60 days of index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Nov 2020
- Primary completion30 Sep 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Bell, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973044
- Sponsor's protocol ID
- Nightingale RR study
- Acronym
- CIM-LOS
- Status last verified
- Mar 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Continuous and Intermittent Monitoring of Abnormal Respiratory and Heart Rate in Relation to Length of Stay. A Clinical Multicenter Study of Continuous Wireless Monitoring Within the NIGHTINGALE Project
- ClinicalTrials.gov ID
- NCT06973044
- Acronym / sponsor ID
- CIM-LOS / Nightingale RR study
- Conditions
- Perioperative Complication, Perioperative/Postoperative Complications, Surgery-Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 May 2025 (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.
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?
Detailed description
Tachypnea is not just a sign of ventilatory problems with hypoxia, but also a precursor of sepsis, metabolic acidosis and severe pain reflecting its role as an indicator of severe derangement in many body systems. A high respiratory rate has been shown to be the most reliable vital sign to predict clinical deterioration, cardiac arrest and is even associated with higher mortality rates. Despite this, it is the vital parameter most neglected; poorly documented or not recorded at all. Studies have shown that respiratory rate is measured in less than half of cases consequently jeopardizing patient safety. The lack of understanding why respiratory rate is important and its superiority to pulse oximetry in predicting clinical deterioration may be one of the reasons why it is not measured accurately.
Badawy and colleagues stated in their study "Is everyone really breathing 20 times a minute?" that respiratory rate was inaccurately recorded and had little variation in the recordings, even in patients with cardiopulmonary compromise, findings that's been supported with later studies. Respiratory rate has traditionally not been objectively measured in general wards, but instead calculated manually over 30 seconds or a minute. This could be changed by new wireless monitoring technology. A recent large study showed that continuous measured respiratory rate together with heart rate and age in a clinical deterioration model outperformed traditional early warning scores in predicting ICU admission.
The present study evaluates heart rate and respiratory rate measured continuously with a new wireless sensor as compared to standard care, with manually measured spot checks by nurses on general wards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical high-risk patients, treated at Karolinska University Hospital and UMC Utrecht
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (3 listed)
- pregnancy
- presence of implantable defibrillator or pacemaker
- allergy to skin adhesives
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 |
|---|---|---|
| Checkpoint Cardio wireless continuous monitoring deviceContinuous monitoring of respiratory rate and heart rate | Device | – |
Primary outcome
Length of stay
Time frame: Within 60 days of index surgery
Time from index surgery to hospital discharge
2 secondary outcomes
Frequency of monitoring
Time frame: Within 60 days of index surgery
Abnormal respiratory rate and abnormal heart rate
Time frame: Within 60 days of index surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Complication and Perioperative/Postoperative Complications, run by Karolinska Institutet at 2 sites in Sweden.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: Within 60 days of index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.