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Procedure

ABCDE for Hyperthermia

N/A

Recruiting

Led By sessled@ccf.org Sessler, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

Study Summary

This trial will test four warming devices and five warming blankets to see which ones work best at keeping people warm. They will measure how much heat is lost or gained on the skin of volunteers who are not

Who is the study for?

This trial is for healthy volunteers aged 18-40 with a body-mass index (BMI) between 20 and 33. Participants should be in good physical condition, classified as ASA Physical Status 1 or 2, which means they have no or only mild systemic disease.Check my eligibility

What is being tested?

The study tests the effectiveness of four different warming devices connected to five types of full-body blankets in preventing heat loss. Volunteers will not be under anesthesia and will experience each blanket-device combination through random assignment.See study design

What are the potential side effects?

Since this trial involves non-invasive warming blankets on unanesthetized participants, side effects are expected to be minimal but may include discomfort due to warmth or lying still for the duration of the measurement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Heat transfer, thermal flux

Secondary outcome measures

Thermal comfort

Trial Design

5Treatment groups

Experimental Treatment

Group I: EADBCExperimental Treatment5 Interventions

E. Volunteers will be covered with the blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. B. Finally and after a last 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. C. Finally and after a last 40-minute washout period, the volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes.

Group II: DCAEBExperimental Treatment5 Interventions

D. Volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. C. After a 40-minute washout period, the volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. B. Finally and after a last 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes.

Group III: CEBADExperimental Treatment5 Interventions

C. Volunteers will be covered with the blanket full body, 30000 blanket connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. B. After a 40-minute washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. A. After a 40-minute washout period, the volunteers will be covered with the adult blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. Finally and after a last 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes.

Group IV: BDECAExperimental Treatment5 Interventions

B. Volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. E. After a 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes. C. After a 40-minute washout period, the volunteer will be covered with the Blanket full body, 30000 connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. A. Finally and after a last 40-minute washout period, the volunteers will be covered with the Adult Blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes.

Group V: ABCDEExperimental Treatment5 Interventions

A. Volunteers will be covered with the Adult Blanket plus, MA2220 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. B. After a 40 minutes washout period, the volunteers will be covered with the Premium Adult Blanket, 3320 connected to the Mistral Air, Blower MA1200-PM system for 30 minutes. C. After a 40-minute washout period, the volunteers will be covered with the Blanket full body, 30000 connected to the 3M, Bair Hugger, Blower 775 for 30 minutes. D. After a 40-minute washout period, the volunteers will be covered with the FilteredFlo® Air Blanket connected to the WarmAir® Convective Warming system for 30 minutes. E. Finally and after a last 40-minute washout period, the volunteers will be covered with the Blanket Full Body blanket (CLM0101) connected to the Care Essential, Cocoon, Blower CWS5000 system for 30 minutes.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,365,538 Total Patients Enrolled

2 Trials studying Hyperthermia

306 Patients Enrolled for Hyperthermia

The Surgical CompanyUNKNOWN

sessled@ccf.org Sessler, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"As per clinicaltrials.gov, this investigation is actively pursuing participants. The trial was initially published on February 15th, 2024, with the latest update recorded on February 19th of the same year."

Answered by AI

What is the current number of participants being admitted into this research trial?

"Indeed, information available on clinicaltrials.gov indicates that this investigation is actively seeking volunteers. Initially shared on February 15th, 2024, the trial's most recent update was made on February 19th, 2024. The research team aims to enroll 20 subjects at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heat Loss in Humans Covered With Full-Body Blankets Connected to Different Warming Devices

2024. "Heat Loss in Humans Covered With Full-Body Blankets Connected to Different Warming Devices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06198959.

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