ParesthesiaNCT06088823
Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course
An observational study of Paresthesia and Peri-operative Injury, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
To describe the incidence and severity of Paresthesia in Hand and Antebrachium in patients that have undergone CardiacSurgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paresthesia, Peri-operative Injury, Complication,Postoperative
- What is being tested?
- Heart surgery
- How many people
- 361 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Oct 2023to 9 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- adult patients
- cardiac surgery in the period from january 2022 to december 2023
- perioperative data entered into the quality database SafeBrain
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Heart surgery
- Keywords
- paresthesia upper limb, cardiac surgery, peri-operative complication
- Medical subject headings
- Paresthesia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart surgeryOther
Adult cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| No paresthesia | Patients that had no registration of post-operative paresthesia in hand or lower arm after cardiac surgery Receives: Other: Heart surgery | |
| Paresthesia | Patients that had one o more registrations of post-operative paresthesia in hand or lower arm after cardiac surgery Receives: Other: Heart surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: January 2022 - december 2023
Secondary outcomes (2)
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
Measured: January 2022 - december 2023
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
Measured: January 2022 - december 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start6 Oct 2023
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParesthesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vibeke Lind Jørgensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088823
- Sponsor's protocol ID
- kandidatopgave NFL 2023
- Status last verified
- Sep 2024
- First submitted
- 12 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course
- ClinicalTrials.gov ID
- NCT06088823
- Acronym / sponsor ID
- kandidatopgave NFL 2023
- Keywords
- paresthesia upper limb, cardiac surgery, peri-operative complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No paresthesia | – | Other: Heart surgeryPatients that had no registration of post-operative paresthesia in hand or lower arm after cardiac surgery |
| Paresthesia | – | Other: Heart surgeryPatients that had one o more registrations of post-operative paresthesia in hand or lower arm after cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- adult patients
- cardiac surgery in the period from january 2022 to december 2023
- perioperative data entered into the quality database SafeBrain
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart surgeryAdult cardiac surgery | Other | No paresthesia, Paresthesia |
Primary outcome
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
2 secondary outcomes
Risk factors for development og paresthesia in hand or lower arm after cardiac surgery
Time frame: January 2022 - december 2023
The clinical course of paresthesia in hand or lower arm after cardiac surgery
Time frame: January 2022 - december 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paresthesia and Peri-operative Injury, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of paresthesia in hand or lower arm after cardiac surgery (time frame: January 2022 - december 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.