NCT05915234

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.

Trial Health

53
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Dec 2026

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
3.4 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

June 4, 2023

Last Update Submit

August 17, 2025

Conditions

TemperatureBlood Flow VelocityRadial Artery Size

Keywords

CryotherapySkin temperatureRadial arteryHemodynamics

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Change in radial artery size

    0-20 minutes

  • Change in radial artery blood flow

    0-20 minutes

Other Outcomes (5)

  • Discomfort

    After 5 minutes from the application of the intervention

  • Discomfort

    After 10 minutes from the application of the intervention

  • Discomfort

    After 15 minutes from the application of the intervention

  • +2 more other outcomes

Study Arms (6)

Order number 1: Ice-Peas-Control

EXPERIMENTAL

Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: crushed ice - frozen peas - control.

Device: Crushed iceDevice: Frozen peasDevice: Room temperature gel

Order number 2: Ice-Control-Peas

EXPERIMENTAL

Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: crushed ice - control - frozen peas.

Device: Crushed iceDevice: Frozen peasDevice: Room temperature gel

Order number 3: Peas-Ice-Control

EXPERIMENTAL

Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: frozen peas - crushed ice - control.

Device: Crushed iceDevice: Frozen peasDevice: Room temperature gel

Order number 4: Peas-Control-Ice

EXPERIMENTAL

Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: frozen peas - control - crushed ice.

Device: Crushed iceDevice: Frozen peasDevice: Room temperature gel

Order number 5: Control-Ice-Peas

EXPERIMENTAL

Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: control - crushed ice - frozen peas.

Device: Crushed iceDevice: Frozen peasDevice: Room temperature gel

Order number 6: Control-Peas-Ice

EXPERIMENTAL

Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: control - frozen peas - crushed ice.

Device: Crushed iceDevice: Frozen peasDevice: Room temperature gel

Interventions

Crushed iceDEVICE

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.

Also known as: ih1
Order number 1: Ice-Peas-ControlOrder number 2: Ice-Control-PeasOrder number 3: Peas-Ice-ControlOrder number 4: Peas-Control-IceOrder number 5: Control-Ice-PeasOrder number 6: Control-Peas-Ice
Frozen peasDEVICE

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.

Also known as: ig2
Order number 1: Ice-Peas-ControlOrder number 2: Ice-Control-PeasOrder number 3: Peas-Ice-ControlOrder number 4: Peas-Control-IceOrder number 5: Control-Ice-PeasOrder number 6: Control-Peas-Ice
Room temperature gelDEVICE

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.

Also known as: ctrl
Order number 1: Ice-Peas-ControlOrder number 2: Ice-Control-PeasOrder number 3: Peas-Ice-ControlOrder number 4: Peas-Control-IceOrder number 5: Control-Ice-PeasOrder number 6: Control-Peas-Ice

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good general health.
  • Conscientious, with full cognitive and communicative capacity.
  • Signed informed consent for this randomized clinical trial.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerencia de Atención Integrada de Talavera de la Reina

Talavera de la Reina, Toledo, 45600, Spain

Location

Study Officials

  • Ignacio Zaragoza García, RN, PhD

    Universidad Complutense de Madrid

    STUDY DIRECTOR

  • Ismael Ortuño Soriano, RN, PhD

    Universidad Complutense de Madrid

    STUDY DIRECTOR

  • Paloma Posada Moreno, PhD

    Universidad Complutense de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study uses a single-blind masking. The 2 interventions and the comparator are contained in opaque bags, that prevents participants from having visual knowledge of the contents of the bags.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized experimental model in which 2 active cryotherapy interventions and a control are applied to all participants in a crossover single-blind design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2023

First Posted

June 22, 2023

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations

ES(1)