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Device

Heated Systems for Maintaining Body Temperature in Pediatric Surgery (ANAPOD Trial)

N/A

Recruiting

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Pediatric patients undergoing elective, scheduled dental procedures at Masonic Children's hospital requiring general anesthesia with endotracheal intubation, anticipated to last 1-6 hours or longer

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours

Awards & highlights

ANAPOD Trial Summary

This trial is comparing two different ways to keep patients warm during surgery. The Westmed system uses warm air, and the Bair Hugger Blanket uses warm water.

Who is the study for?

This trial is for pediatric patients who need general anesthesia with endotracheal intubation for dental procedures expected to last between 1-6 hours at Masonic Children's Hospital. It's not suitable for those with temperature regulation diseases, a history of malignant hyperthermia, or if additional non-dental procedures are planned.Check my eligibility

What is being tested?

The study compares the effectiveness of two methods to maintain body temperature during surgery: the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit and the Bair Hugger™ Warming Blanket.See study design

What are the potential side effects?

Potential side effects may include skin irritation from contact with devices, possible burns if equipment malfunctions, and discomfort due to prolonged use of warming devices.

ANAPOD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is scheduled for a dental procedure under general anesthesia expected to last 1-6 hours or more.

ANAPOD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rectal Temperature

Secondary outcome measures

Cumulative degree-minutes above and below 37C

Need for Hyperthermic or Hypothermic Rescue

ANAPOD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Anapod™ Humi-Therm Heated Humidification SystemExperimental Treatment1 Intervention

Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.

Group II: Bair Hugger™ Warming BlanketActive Control1 Intervention

Patient warming will be provided via the Bair Hugger™ Warming Blanket.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,380 Previous Clinical Trials

1,588,486 Total Patients Enrolled

2 Trials studying Fever

163 Patients Enrolled for Fever

Media Library

Anapod™ Humi-Therm Heated Humidification System Breathing Circuit (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03896867 — N/A

Fever Research Study Groups: Anapod™ Humi-Therm Heated Humidification System, Bair Hugger™ Warming Blanket

Fever Clinical Trial 2023: Anapod™ Humi-Therm Heated Humidification System Breathing Circuit Highlights & Side Effects. Trial Name: NCT03896867 — N/A

Anapod™ Humi-Therm Heated Humidification System Breathing Circuit (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03896867 — N/A

Frequently Asked Questions

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

How many participants are eligible to join this medical trial?

"Affirmative, the clinical trial is actively seeking patients. According to information hosted on clinicaltrials.gov, it was initially listed on October 31st 2019 and most recently updated on July 19th 2022. 256 participants are needed from a single medical site for completion of the study's objectives."

Answered by AI

Are there any more slots open for participation in this experiment?

"As verified on clinicaltrials.gov, this medical experiment is actively searching for volunteers and has been since October 31st 2019; the trial's information was most recently updated on July 19th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients

2019. "Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03896867.