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

Complication,Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088823
• Other study ID #: kandidatopgave NFL 2023
• Status: Recruiting
• Start date: October 6, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: October 2023
• Source: Rigshospitalet, Denmark
• Contact: Vibeke Lind Jørgensen, M.D, Ph.D
• Phone: +4535458947
• Email: vibeke.lind.joergensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients

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

• perioperative data entered into the quality database SafeBrain

Related Conditions & MeSH terms

• Complication,Postoperative
• Disease Progression
• Paresthesia
• Peri-operative Injury
• Postoperative Complications
• Upper Limb Nerve Lesion

Locations

Country	Name	City	State
Denmark	Vibeke Renee Lind Jørgensen	København Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk factors for development og paresthesia in hand or lower arm after cardiac surgery	Analysis of the variables collected to identify possible risk factors for development og paresthesia in hand or lower arm after cardiac surgery	January 2022 - december 2023
Secondary	The clinical course of paresthesia in hand or lower arm after cardiac surgery	Qualitative description of the clinical course for paresthesia in hand or lower arm after cardiac surgery	January 2022 - december 2023