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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03944967
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
dr. P. Noordzij, St. Antonius Hospital

Study Description
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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.

Condition or disease
Hypoxemia Respiratory Failure 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.
Criteria

Inclusion Criteria:

  • ≥70 years undergoing elective cardiac surgery.

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944967


Contacts
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Contact: Peter Noordzij 0031883202304 p.noordzij@antoniusziekenhuis.nl

Locations
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Netherlands
St Antonius hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Principal Investigator: Peter Noordzij, MD PhD         
Sponsors and Collaborators
St. Antonius Hospital
More Information
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Responsible Party: dr. P. Noordzij, PI, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT03944967    
Other Study ID Numbers: NL68944.100.19
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory