Effect of Cryotherapy Modalities on Skin Temperature, Radial Artery Size and Flow Where Arterial Puncture Are Performed

Temperature Clinical Trial

— ECCRIOGAS  

Official title:

Analysis of the Effect of Different Cryotherapy Procedures on the Radial Puncture Site for Blood Gas Analysis Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05915234
• Other study ID #: ECCRIOGAS
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Hospital General Nuestra Señora del Prado
• Contact: Julio Alberto Mateos Arroyo, RN, MSc
• Phone: +34 925 80 36 00
• Email: juliomat[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Good general health.

• Conscientious, with full cognitive and communicative capacity.

• Signed informed consent for this randomized clinical trial.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Blood Flow Velocity
• Temperature

Intervention

Device:
• Crushed ice
Each participant will receive two active devices and one sham comparator in a crossover design.The cryotherapy device used consists of an opaque bag with a plastic outer cover and an aluminum interior filled with 80 grams of crushed ice. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed to reduce skin temperature in ranges that decrease nerve conduction velocity and increase pain threshold.
• Frozen peas
Each participant will receive two active devices and one sham comparator in a crossover design. The cryotherapy device used consists of an opaque bag with a plastic outer cover and an aluminum interior filled with 80 grams of frozen peas. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed to reduce skin temperature in ranges that decrease nerve conduction velocity and increase pain threshold.
• Room temperature gel
Each participant will receive two active devices and one sham comparator in a crossover design. The sham comparator device used consists of an opaque bag with an external plastic cover and an aluminum interior filled with 80 grams of ultrasound gel at room temperature. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Julio Alberto Mateos Arroyo	Hospital General Nuestra Señora del Prado, Universidad Complutense de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Discomfort	The discomfort generated by the interventions and the comparator will be recorded 5, 10, 15 and 20 minutes after their application. An ad hoc likert-type numerical scale will be used, where 1 means no discomfort and 10 means extreme discomfort.	After 5 minutes from the application of the intervention
Other	Discomfort	The discomfort generated by the interventions and the comparator will be recorded 5, 10, 15 and 20 minutes after their application. An ad hoc likert-type numerical scale will be used, where 1 means no discomfort and 10 means extreme discomfort.	After 10 minutes from the application of the intervention
Other	Discomfort	The discomfort generated by the interventions and the comparator will be recorded 5, 10, 15 and 20 minutes after their application. An ad hoc likert-type numerical scale will be used, where 1 means no discomfort and 10 means extreme discomfort.	After 15 minutes from the application of the intervention
Other	Discomfort	The discomfort generated by the interventions and the comparator will be recorded 5, 10, 15 and 20 minutes after their application. An ad hoc likert-type numerical scale will be used, where 1 means no discomfort and 10 means extreme discomfort.	After 20 minutes from the application of the intervention
Other	Adverse events	Number of participants with adverse events	Through study completion, an average of 3 months
Primary	Skin temperature	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.	Prior to application of the intervention
Primary	Skin temperature	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.	After 5 minutes from the application of the intervention
Primary	Skin temperature	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.	After 10 minutes from the application of the intervention
Primary	Skin temperature	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.	After 15 minutes from the application of the intervention
Primary	Skin temperature	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.	After 20 minutes from the application of the intervention
Secondary	Change in radial artery size	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.	0-20 minutes
Secondary	Change in radial artery blood flow	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.	0-20 minutes