Effect of Cryotherapy Modalities on Skin Temperature, Radial Artery Size and Flow Where Arterial Puncture Are Performed
- Conditions
- Blood Flow VelocityTemperatureRadial Artery Size
- Registration Number
- NCT05915234
- Lead Sponsor
- Julio Alberto Mateos Arroyo
- Brief Summary
Low-intervention clinical trial. The thermal and hemodynamic effects of different cryotherapy devices are evaluated. This study is included in the doctoral thesis of the principal investigator.
Investigators:
Principal Investigator: Julio Alberto Mateos Arroyo (RN, MSc, PhD student) Directors: Ignacio Zaragoza García (RN, PhD), Ismael Ortuño Soriano (RN, PhD), Paloma Posada Moreno (PhD).
Setting: Faculty of Nursing, Physiotherapy and Podiatry of the Universidad Complutense de Madrid.
The three interventions to be evaluated are:
* Applying crushed ice.
* Apply frozen peas.
* Apply comparator.
Hypothesis: There are differences in the reduction of temperature, dimensions of the internal lumen of the radial artery and blood flow inside it depending on the different modalities of cryotherapy (crushed ice or bag of frozen peas) applied in the anatomical area of the wrist, point of arterial puncture for blood gas analysis.
Main objective: To analyze the effect of 3 cryotherapy devices on the radial artery area.
Secondary objectives
* To analyze the thermal behavior of the superficial tissue under study according to the cryotherapy device used.
* To analyze the differences in the radial artery caliber before and after the application of cold in the different experimental modalities under study.
* To analyze the differences in radial artery blood flow before and after the application of cold in the different experimental modalities under study.
* To identify the safety pattern of the use of the different cryotherapy devices (adverse events).
Design: Randomized controlled clinical trial. This is a crossover clinical trial in which all participants will receive all interventions and will be randomized in the order in which they receive them.
Population: Adults with a good general state of health, who specifically do not have factors that could affect their thermoregulation or vascular pathologies.
Main variables:
* Skin surface temperature.
* Radial artery size.
* Radial artery blood flow.
- Detailed Description
Pain caused by arterial puncture for blood gas analysis is one of the most common problems with this procedure. The low utilization rates of effective methods by healthcare providers for pain reduction, such as subcutaneous infiltration of anesthetics, make it necessary to search for effective and simple methods. The use of cryotherapy devices has proven effective for this purpose because the decrease in temperature increases pain threshold and tolerance due to a reduction in nerve conduction velocity and inhibition of nociceptors. In order to standardize these devices, it is necessary to understand the specific thermodynamic and hemodynamic effects of these devices. At the hemodynamic level, the reduction in temperature can produce arterial vasoconstriction. This effect may decrease the palpation of the radial artery, a necessary step for the identification of the optimal point of arterial puncture. Our hypothesis is that there are differences in temperature reduction, radial artery internal lumen dimensions and blood flow inside the radial artery depending on the different cryotherapy modalities applied in the anatomical area of the wrist, the point of arterial puncture for blood gas analysis. In order to obtain an answer to this hypothesis, we will propose a randomized controlled clinical trial with a sham comparator and two active interventions: crushed ice and frozen peas. In addition, this trial has a crossover design with the aim of minimizing the differences that may arise due to individual particularities (within-group variability), and thus increase the possible effect of the interventions (between-group variability). This choice has its justification in that the application of cryotherapy, according to some studies, has a thermal reducing effect with high individual variability. In this study, adults with a good general state of health, who specifically do not have factors that could affect their thermoregulation or vascular pathologies, will be recruited.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
- Good general health.
- Conscientious, with full cognitive and communicative capacity.
- Signed informed consent for this randomized clinical trial.
- Active smoker.
- Cardiovascular disease.
- Peripheral vascular disease.
- Cyanosis of hands and fingers, Raynaud's Syndrome, Scleroderma and/or CREST Syndrome.
- Diabetes.
- Surgery, recent wounds or any type of major injury affecting the neck, shoulder girdle, upper limbs and/or hands.
- Carrier of an arterio-venous fistula.
- Lack of sensitivity to cold.
- Alcohol or caffeine intake in the last 24 hours.
- Intense physical exercise in the last 24 hours.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Skin temperature After 20 minutes from the application of the intervention Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity \<70ºC mK, resolution 160 X 120.
- Secondary Outcome Measures
Name Time Method Change in radial artery size 0-20 minutes Three measurements of the anteroposterior diameter of the radial artery will be taken in the same place and plane to ensure reliability at each time point studied. Samsung HS50 ultrasound scanner with a 3-14 Hz linear probe will be used for the measurement.
Change in radial artery blood flow 0-20 minutes To obtain the blood flow of the radial artery, color Doppler mode will be used to correctly identify the vessel and then the pulsed Doppler mode will be used to obtain the peak systolic low (PSV), that is, the maximum systolic velocity (VSM). Three consecutive PSV measurements will be obtained in the same place and plane to ensure reliability at each time point studied. Samsung HS50 ultrasound scanner with a 3-14 Hz linear probe will be used for the measurement.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.