NCT03944967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

March 5, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2021

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

April 22, 2019

Last Update Submit

November 20, 2023

Conditions

HypoxemiaRespiratory FailureArrythmia

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ≥70 years undergoing elective cardiac surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

MeSH Terms

Conditions

HypoxiaRespiratory InsufficiencyArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 22, 2019

First Posted

May 10, 2019

Study Start

March 5, 2020

Primary Completion

December 19, 2021

Study Completion

December 19, 2021

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

NL(1)