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Completed

NCT Number: NCT03944967

Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

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.

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Key information

Conditions

Hypoxemia Arrhythmias, Cardiac Arrythmia Cardiovascular Diseases Heart Diseases Hypoxia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Antonius hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥70 years undergoing elective cardiac surgery.

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Hypoxemia

    Time frame: Three consecutive days after ICU discharge

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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Acronym: AGEAWARE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 10, 2019
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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