Pre op lower body forced air warming (32˚C) for Hypothermia

The University of Texas Health Science Center at Houston, Houston, TX
Hypothermia+2 More ConditionsPre op lower body forced air warming (32˚C) - Device
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is trying to find the best way to keep mothers warm during surgery and how temperature changes affect the mother and baby.

Eligible Conditions
  • Hypothermia
  • Hypothermia, Anesthesia
  • Neonatal Hypothermia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

5 Primary · 5 Secondary · Reporting Duration: 10 minutes after birth

10 minutes after birth
Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score
Neonate status as determined by Umbilical Artery PH
Hour 72
Hospital Length of Stay
after 30 minutes in PACU
Number of patients that need meperidine
after administration of meperidine, if it applies (about 30 minutes in PACU)
Shivering
Hour 4
Blood Coagulation Disorders
Number of patients that show Maternal thermal comfort
Hour 4
Perioperative blood loss
Hour 4
Change in maternal core body temperature
Number of women with hypothermia

Trial Safety

Phase-Based Safety

1 of 3

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1
Moderate neuromuscular blockade (MNB)
2
Dantrolene/Ryanodex
3
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control Group
1 of 2
Treatment
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Pre op lower body forced air warming (32˚C) · No Placebo Group · N/A

TreatmentExperimental Group · 9 Interventions: Pre op upper body forced air warming (32˚C), Intra op upper body forced air warming at (32˚C), Intra op upper body forced air warming at (42˚C), Pre op fluids (45˚C), Intra op upper body forced air warming (32˚C), Intra op lower body forced air warming at (32˚C), Pre op lower body forced air warming (32˚C), Intra op lower body forced air warming at (42˚C), Intra op fluid (42˚C) · Intervention Types: Device, Device, Device, Device, Device, Device, Device, Device, Device
Control GroupActiveComparator Group · 6 Interventions: Pre op upper body forced air warming (32˚C), Intra op upper body forced air warming at (32˚C), Pre op fluids (45˚C), Intra op upper body forced air warming (32˚C), Pre op lower body forced air warming (32˚C), Intra op fluids at room temperature · Intervention Types: Device, Device, Device, Device, Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 minutes after birth

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
835 Previous Clinical Trials
263,817 Total Patients Enrolled
2 Trials studying Hypothermia
262 Patients Enrolled for Hypothermia
Stacy Norrell, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are pregnant with one baby.
References

Frequently Asked Questions

Are there still openings in this experiment for participants?

"True, according to clinicaltrials.gov this medical trial is actively recruiting volunteers. It was initially posted on August 23rd 2021 and recently updated on January 6th 2023; the researchers are searching for 100 patients from a single location." - Anonymous Online Contributor

Unverified Answer

What is the aggregate amount of individuals participating in this experiment?

"Affirmative, the listing on clinicaltrials.gov demonstrates that this study is currently recruiting volunteers. This trial was initially posted on August 23rd 2021 and has since had its information updated as recently as January 6th 2023. At present, 100 individuals are needed at 1 medical centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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