Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03944967

Acronym

AGEAWARE

Enrollment

Registered

2019-05-10

Start date

2020-03-05

Completion date

2021-12-19

Last updated

2023-11-21

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

Conditions

Arrythmia, Hypoxemia, Respiratory Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥70 years undergoing elective cardiac surgery.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Hypoxemia	Three consecutive days after ICU discharge	Duration of sPO2 \<80%, \<85%, \<90% and \<95% in minutes per hour
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

Countries

Netherlands

Outcome results