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

Completed

• Conditions: Perioperative Complication; Perioperative/Postoperative Complications; Surgery-Complications

• Registration Number: NCT06973044
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-09-30
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of stay	Within 60 days of index surgery	Time from index surgery to hospital discharge

Secondary Outcome Measures

Name	Time	Method
Frequency of monitoring	Within 60 days of index surgery	Time spent on continuous and intermittent monitoring
Abnormal respiratory rate and abnormal heart rate	Within 60 days of index surgery	Time spent in predefined abnormal RR and HR, with continuous and intermittent monitoring

Trial Locations

Locations (2)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Karolinska Institutet; 🇸🇪 Stockholm, Sweden