Carotid Artery Diseases, Distress, Procedural, Regional Anesthesia
Conditions
Keywords
video googles, carotid endarterectomy, distress in patients, vascular surgery
Brief summary
One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia. In many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.
Interventions
DEVICEvideo googles
Patients undergoing surgery use video googles and a headphone to distract from surgery
Sponsors
HappyMed GmbH (Wien, Austria)
University Hospital Augsburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planed carotid endarterectomy in local anesthesia
Exclusion criteria
* patients which are not able to communicate because of stroke or language barrier, * Dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery * medication with steroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bloodserum cortisol levels | Cortisol levels are measured six times the day the procedure is performed. Starting at 6:30am, Arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR | cortisol levels in the blood are measured on six specific times in the perioperative setting |
| Heartrate | The heartrate is measured six times the day the procedure is performed. Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR | The heart rate is measured on six specific times in the perioperative setting |
| short questionnaire on current stress | The questionnaire is asked six times the day the procedure is performed. Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR | The short questionnaire on current stress; is measured on six specific times in the perioperative setting. It is a validated score to measure actual stress, there are 6 items, with 6 a scale one to six. The minimal score is 6 (low distress) and 36 (high distress) |
| Richmond Agitation-Sedation Scale (RASS) | RASS is measured six times the day the procedure is performed.Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR | TheRichmond Agitation-Sedation Scale (RASS) is measured on six specific times in the perioperative setting. It is a score typically used in anesthesia to measure agitation and sedation. The scale is from +4 (aggressive) over 0 (awake and calm) to -5 (deeply sleeping, not awakable) |
| Spielberger State-Trait Anxiety Inventory (STAI) | One Day. Day before surgery | This questionnaire ist is used to measure general and anxiety related to the current situation (upcoming surgery) Used are two questionnaires with 20 items each, after recoding the answers there is a numeric value for each questionnaire. High values suggest a high feeling of fear, low values, a low feeling of fear. |
| Satisfaction (patient, surgeon, anesthesia) | One day. After surgery, within the next 24 hours | After completing the surgery, all participation parties (patient, surgery and anesthesia) are asked to rate the surgery regarding to calmness of the patient, pain and distress. A numeric rating scale (0-10) is used. |
| Next time again? | One day. After surgery, within the next 24 hours | Patients in the interventional group are asked, if the would like to use the video googles again in case of an other surgery |
| pain, distress, nervousness, fear | Questions are asked six times the day the procedure is performed.Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR | patients are asked if the feel one of the above (using no \[1\] - rather no \[2\] - not sure \[3\] - rather yes \[4\] - yes\[5\]) six specific times in the perioperative setting. For each quality (pain, distress, nervousness, fear) there is measured an individual value |
Countries
Germany
Contacts
Primary ContactHagen Kerndl
Backup ContactThomas Millian
Outcome results
None listed