Continuous vs Intermittent Monitoring of Respiratory and Heart Rate in Relation to Length of Stay (CIM-LOS)

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?

Study Overview

• Status: Completed
• Conditions: Perioperative/Postoperative Complications; Perioperative Complication; Surgery-Complications
• Intervention / Treatment: Device: Checkpoint Cardio wireless continuous monitoring device

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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. ≥ 18 years of age
2. planned to go through a major high-risk surgery
3. American Society of Anesthesiologists (ASA) class 2-4 due to present comorbidities
4. planned to stay in the postoperative high dependency unit for >12hours where they also would have wired continuous monitoring.

Exclusion Criteria:

1. pregnancy
2. presence of implantable defibrillator or pacemaker
3. allergy to skin adhesives

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Time from index surgery to hospital discharge	Within 60 days of index surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of monitoring	Time spent on continuous and intermittent monitoring	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	Within 60 days of index surgery

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: May 7, 2025
• First Submitted That Met QC Criteria: May 7, 2025
• First Posted (Actual): May 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: Nightingale RR study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No