Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients (AGEAWARE)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Hypoxemia; Arrythmia

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 Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • St Antonius hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• ≥70 years undergoing elective cardiac surgery.

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): December 19, 2021
• Study Completion (Actual): December 19, 2021

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia
• Other Study ID Numbers: NL68944.100.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No