Postoperative Remote Monitoring of Vital Signs in Older C... | NCT03944967

Studies
Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

NCT03944967

Sponsor

St. Antonius Hospital

Status

Completed

Last Update Posted

Nov 21, 2023Actual

Enrollment

71Actual

Phase

Not provided

Conditions

Hypoxemia
Respiratory Failure
Arrythmia

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2020Actual

Primary Completion Date

Dec 19, 2021Actual

Completion Date

Dec 19, 2021Actual

First Submitted Date

Apr 22, 2019

First Submission Date that Met QC Criteria

May 8, 2019

First Posted Date

May 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥70 years undergoing elective cardiac surgery.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Antonius hospital		Nieuwegein	Utrecht	3435 CM	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia
D012131	Respiratory Insufficiency
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012120	Respiration Disorders

Browse Leaves

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Browse Branches

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