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Clinical Trials/NCT03944967
NCT03944967
Completed
Not Applicable

Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

St. Antonius Hospital1 site in 1 country71 target enrollmentMarch 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxemia
Sponsor
St. Antonius Hospital
Enrollment
71
Locations
1
Primary Endpoint
Respiratory deterioration
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 5, 2020
End Date
December 19, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr. P. Noordzij

PI

St. Antonius Hospital

Eligibility Criteria

Inclusion Criteria

  • ≥70 years undergoing elective cardiac surgery.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Respiratory deterioration

Time Frame: 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

Time Frame: 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

Time Frame: Three consecutive days after ICU discharge

Duration of sPO2 \<80%, \<85%, \<90% and \<95% in minutes per hour

Study Sites (1)

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