NCT06088823

Brief Summary

To describe the incidence and severity of Paresthesia in Hand and Antebrachium in patients that have undergone CardiacSurgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 6, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

October 12, 2023

Last Update Submit

September 12, 2024

Conditions

Keywords

paresthesia upper limbcardiac surgeryperi-operative complication

Outcome Measures

Primary Outcomes (1)

  • Incidence of paresthesia in hand or lower arm after cardiac surgery

    The number of patients with paresthesia in hand or lower arm after cardiac surgery, compared to total number of patients operated in the time period

    January 2022 - december 2023

Secondary Outcomes (2)

  • Risk factors for development og paresthesia in hand or lower arm after cardiac surgery

    January 2022 - december 2023

  • The clinical course of paresthesia in hand or lower arm after cardiac surgery

    January 2022 - december 2023

Study Arms (2)

No paresthesia

Patients that had no registration of post-operative paresthesia in hand or lower arm after cardiac surgery

Other: Heart surgery

Paresthesia

Patients that had one o more registrations of post-operative paresthesia in hand or lower arm after cardiac surgery

Other: Heart surgery

Interventions

Adult cardiac surgery

No paresthesiaParesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients accepted for elective cardiac surgery, where peri-operative data have been entered in to the on-going quality databse SafeBrain (data protection journal number P-2020-27, Department of Healthcare law and dataprotection 1141, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen east, Denmark).

You may qualify if:

  • adult patients
  • cardiac surgery in the period from january 2022 to december 2023
  • perioperative data entered into the quality database SafeBrain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vibeke Renee Lind Jørgensen

København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

ParesthesiaPostoperative Complications

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, PhD, principal investigator

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

October 6, 2023

Primary Completion

January 9, 2024

Study Completion

January 9, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations