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OpenTrials
Completed

NCT Number: NCT06973044

Continuous vs Intermittent Monitoring of Respiratory and Heart Rate in Relation to Length of Stay

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet, Stockholm, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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.

Exclusion criteria

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

Treatment and study plan

Checkpoint Cardio wireless continuous monitoring device

Device

Continuous monitoring of respiratory rate and heart rate

Primary outcomes

  1. Length of stay

    Time frame: Within 60 days of index surgery

    Time from index surgery to hospital discharge

Secondary outcomes

  1. Frequency of monitoring

    Time frame: Within 60 days of index surgery

    Time spent on continuous and intermittent monitoring

  2. Abnormal respiratory rate and abnormal heart rate

    Time frame: Within 60 days of index surgery

    Time spent in predefined abnormal RR and HR, with continuous and intermittent monitoring

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Acronym: CIM-LOS

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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