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CompletedNCT06088823Updated Sep 19, 2024

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

An observational study in Paresthesia, Peri-operative Injury and Complication,Postoperative, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
361
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • paresthesia upper limb
  • cardiac surgery
  • peri-operative complication
03

In context

Paresthesia

66 studies on the registry are indexed under Paresthesia; 14 are open to participants now.

This study's enrollment of 361 is above the median of 110 across 12 observational studies indexed under Paresthesia.

Browse Paresthesia studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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).

Eligibility criteria

Inclusion Criteria:

  • adult patients
  • cardiac surgery in the period from january 2022 to december 2023
  • perioperative data entered into the quality database SafeBrain
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
361 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherHeart surgery

    Adult cardiac surgery

06

What researchers measure

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

    Time frame: January 2022 - december 2023

Secondary outcomes

  1. 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

    Time frame: January 2022 - december 2023

  2. 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

    Time frame: January 2022 - december 2023

07

Study locations

1 site
  • Vibeke Renee Lind Jørgensen
    København Ø, 2100, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06088823
Responsible party
Vibeke Lind Jørgensen (Consultant, PhD, principal investigator, Rigshospitalet, Denmark) — Principal investigator
First posted
Oct 18, 2023
Start date
Oct 6, 2023
Primary completion
Jan 9, 2024
Completion
Jan 9, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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