Clinical trial NCT06088823: Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course
Official title: Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paresthesia
Peri-operative Injury
Complication,Postoperative
Upper Limb Nerve Lesion
Keywords: paresthesia upper limb
cardiac surgery
peri-operative complication
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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

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.

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

Primary outcomes:
measure: Incidence of paresthesia in hand or lower arm after cardiac surgery
timeFrame: January 2022 - december 2023
Secondary outcomes:
measure: Risk factors for development og paresthesia in hand or lower arm after cardiac surgery
timeFrame: January 2022 - december 2023
measure: The clinical course of paresthesia in hand or lower arm after cardiac surgery
timeFrame: January 2022 - december 2023
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Vibeke Renee Lind Jørgensen
Study officials:
References: