- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06088823
Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course
Study Overview
Status
Intervention / Treatment
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.
The study included 361 patients. Conclusion The incidence of hand paresthesia following cardiac surgery was 10%. This study found an increased occurrence of paresthesia after aortic valve surgery and prolonged aortic cross-clamp duration; these differences were not statistically significant. The impact of arterial line placement and patient positioning as a risk factor remains unclear. The majority of patients with paresthesia were overweight and had pre-existing comorbidity, with 11% reporting preoperative paresthesia. The clinical course of hand paresthesia following cardiac surgery was predominantly transient and not severe.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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København Ø, Denmark, 2100
- Vibeke Renee Lind Jørgensen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients
- cardiac surgery in the period from january 2022 to december 2023
- perioperative data entered into the quality database SafeBrain
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
No paresthesia
Patients that had no registration of post-operative paresthesia in hand or lower arm after cardiac surgery
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Adult cardiac surgery
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Paresthesia
Patients that had one o more registrations of post-operative paresthesia in hand or lower arm after cardiac surgery
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Adult cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of paresthesia in hand or lower arm after cardiac surgery
Time Frame: 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
|
January 2022 - december 2023
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors for development og paresthesia in hand or lower arm after cardiac surgery
Time Frame: 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
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January 2022 - december 2023
|
|
The clinical course of paresthesia in hand or lower arm after cardiac surgery
Time Frame: January 2022 - december 2023
|
Qualitative description of the clinical course for paresthesia in hand or lower arm after cardiac surgery
|
January 2022 - december 2023
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kandidatopgave NFL 2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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