Use of Water Warming/Cooling Garment to Maintain a Constant Intraoperative Core Target Temperature in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC): A Proof-of-Concept Study

Last updated: May 4, 2023
Sponsor: M.D. Anderson Cancer Center
Overall Status: Trial Not Available

Phase

1

Condition

Fever

Treatment

Allon System

Clinical Study ID

NCT05474352
2022-0159
NCI-2022-05348
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To look at the feasibility of using a water warming/cooling garment (called the ALLON system) to maintain a target body temperature during surgery and chemotherapy perfusion (a method of pouring chemotherapy throughout your abdominal cavity) without overheating or overcooling your body.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults patients (>18 years old)
  • Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy with an expectedduration of perfusion longer than 60 minutes
  • Signed informed consent

Exclusion

Exclusion criteria:

  • America Society of Anesthesiology (ASA)physical status >4
  • Patient undergoing cytoreductive surgery with hyperthermic intraperitonealchemotherapy for recurrent disease.
  • Patients with open wounds
  • Patients with a history of thermoregulatory diseases such as spinal cord injury,thyroid disease, and malignant hyperthermia.

Study Design

Treatment Group(s): 1
Primary Treatment: Allon System
Phase: 1
Study Start date:
June 14, 2022
Estimated Completion Date:
May 03, 2023

Study Description

Objectives:

Primary Objectives:

To evaluate the feasibility of using a water warming/cooling garment (Allon system) to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy while avoiding core (esophageal) hyperthermia (≥39.5°C).

Secondary Objective:

To evaluate the safety for all study participants when using of the Allon system strategy in achieving and maintaining a bladder temperature of ≥38°C for at least 30 minutes or longer during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy while avoiding core hyperthermia (≥39°C)

Connect with a study center

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.