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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

Clinicaltrials.gov identifier NCT03944967

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted March 19, 2020

Study Description

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
  • Intervention/Treatment:
  • Phase: N/A
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
  • 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 2020
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: September 2020
Outcome Measures
  • 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
  • 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
Contacts

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

Locations

Netherlands, Utrecht
St Antonius hospital
Nieuwegein

Sponsors and Collaborators

St. Antonius Hospital

More Information
  • Responsible Party: St. Antonius Hospital
  • ClinicalTrials.gov Identifier: NCT03944967 History of Changes
  • Other Study ID Numbers: NL68944.100.19
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: March 19, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Respiratory Insufficiency Hypoxia