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NCT03944967 Clinical Trial

Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

Respiratory Failure Clinical Trial

— AGEAWARE  

Official title:
Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03944967
Other study ID # NL68944.100.19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 5, 2020
Est. completion date December 19, 2021

Study information
Verified date November 2023
Source St. Antonius Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date December 19, 2021
Est. primary completion date December 19, 2021
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - =70 years undergoing elective cardiac surgery. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands St Antonius hospital Nieuwegein Utrecht

Sponsors (1)
Lead Sponsor Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypoxemia Duration of sPO2 <80%, <85%, <90% and <95% in minutes per hour Three consecutive days after ICU discharge
Primary Respiratory deterioration Duration of respiratory rate <10 min-1, >20 min-1, >25 min-1, >30 min-1 in minutes per hour Three consecutive days after ICU discharge
Primary Arrythmia Duration of pulse rate <50 min-1, >100 min-1, >110 min-1, >120 min-1 in minutes per hour Three consecutive days after ICU discharge
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