Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

Completed

• Conditions: Respiratory Failure; Arrythmia; Hypoxemia

• Registration Number: NCT03944967
• Lead Sponsor: St. Antonius Hospital

Brief Summary

A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients.

* Single center pilot study.

* 100 older patients undergoing cardiac surgery.

* Continuous remote monitoring of vital signs after ICU discharge

* Main study endpoint is vital sign deterioration.

Detailed Description

Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery.

To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..

* Single center pilot study.

* 100 older patients undergoing cardiac surgery.

* Continuous remote monitoring of vital signs starts after ICU discharge

* PR, RR and SpO2 will be continuously monitored in all patients.

* Patients and healthcare personnel are blinded for monitoring results.

* Main study endpoint is vital sign deterioration.

The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Study Start: 2020-03-05
• Primary Completion: 2021-12-19
• Study Completion: 2021-12-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• ≥70 years undergoing elective cardiac surgery.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory deterioration	Three consecutive days after ICU discharge	Duration of respiratory rate \<10 min-1, \>20 min-1, \>25 min-1, \>30 min-1 in minutes per hour
Arrythmia	Three consecutive days after ICU discharge	Duration of pulse rate \<50 min-1, \>100 min-1, \>110 min-1, \>120 min-1 in minutes per hour
Hypoxemia	Three consecutive days after ICU discharge	Duration of sPO2 \<80%, \<85%, \<90% and \<95% in minutes per hour

Trial Locations

Locations (1)

St Antonius hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands