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Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT06088823
Collaborator
(none)
600
Enrollment
1
Location
2.9
Anticipated Duration (Months)
209.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Some patients report tingling and/or numbness in hand and/or antebrachium after cardiac surgery, but potential risc factors and clinical course are not well described, and the incidence or severity is not known. Many factors may impact on the development of these complaints: age, BMI, pre-operative neurological deficits, diabetes, type, technique and duration of cardiac surgery, positioning of arms and hands during surgery, placement of the arterial line, time-to-extubation and post-operative positioning during this period.

    The investigators aim to describe incidence and clinical course of these complaints and possibly identify modifiable risc factors in a retrospective cohort of patients that have undergone fast-track cardiac surgery, as a part of the on-going patient-centered quality improvement.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course
    Actual Study Start Date :
    Oct 6, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    No paresthesia

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of paresthesia in hand or lower arm after cardiac surgery [January 2022 - december 2023]

      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

    Secondary Outcome Measures

    1. Risk factors for development og paresthesia in hand or lower arm after cardiac surgery [January 2022 - december 2023]

      Analysis of the variables collected to identify possible risk factors for development og paresthesia in hand or lower arm after cardiac surgery

    2. The clinical course of paresthesia in hand or lower arm after cardiac surgery [January 2022 - december 2023]

      Qualitative description of the clinical course for paresthesia in hand or lower arm after cardiac surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • adult patients

    • cardiac surgery in the period from january 2022 to december 2023

    • perioperative data entered into the quality database SafeBrain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vibeke Renee Lind Jørgensen København Ø Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vibeke Lind Jørgensen, Consultant, PhD, principal investigator, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT06088823
    Other Study ID Numbers:
    • kandidatopgave NFL 2023
    First Posted:
    Oct 18, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vibeke Lind Jørgensen, Consultant, PhD, principal investigator, Rigshospitalet, Denmark
    paresthesia upper limb
    cardiac surgery
    peri-operative complication
    Additional relevant MeSH terms:
    Paresthesia
    Disease Progression
    Postoperative Complications

    Study Results

    No Results Posted as of Oct 23, 2023