Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06973044
Acronym
CIM-LOS
Enrollment
46
Registered
2025-05-15
Start date
2020-11-01
Completion date
2024-12-31
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Complication, Perioperative/Postoperative Complications, Surgery-Complications

Brief 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 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.

Interventions

DEVICECheckpoint Cardio wireless continuous monitoring device

Continuous monitoring of respiratory rate and heart rate

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of stayWithin 60 days of index surgeryTime from index surgery to hospital discharge

Secondary

MeasureTime frameDescription
Frequency of monitoringWithin 60 days of index surgeryTime spent on continuous and intermittent monitoring
Abnormal respiratory rate and abnormal heart rateWithin 60 days of index surgeryTime spent in predefined abnormal RR and HR, with continuous and intermittent monitoring

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026