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
May 4, 2023 updated by: M.D. Anderson Cancer Center
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed 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)
Study Type
Interventional
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults patients (>18 years old)
- Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy with an expected duration of perfusion longer than 60 minutes
- Signed informed consent
Exclusion criteria:
- America Society of Anesthesiology (ASA)physical status >4
- Patient undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ALLON System
The ALLON system water garment, is like a large apron that covers your body.
There are tubes that run throughout the water garment, which allow warm liquid to flow so that the garment keeps the participant warm.
The ALLON system water garment will be filled with warm water.
|
Water garments (Allon system) already pre-filled with warm water will be set up before induction of anesthesia.
After the induction of general anesthesia, the water garment will cover the lower and upper extremities, the lateral portion of the chest, and the entire back of the patient, which accounts for 70% of the body surface.
The water garment will be opened temporarily on the upper extremities for intravenous access and arterial line placement and will be continued intraoperatively until the patient is transferred from the OR table to the stretcher
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Patients to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer.
Time Frame: through HIPEC surgery (up to 4 hours)
|
through HIPEC surgery (up to 4 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria F Ramirez, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2022
Primary Completion (Actual)
May 3, 2023
Study Completion (Actual)
May 3, 2023
Study Registration Dates
First Submitted
June 20, 2022
First Submitted That Met QC Criteria
July 25, 2022
First Posted (Actual)
July 26, 2022
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0159
- NCI-2022-05348 (Other Identifier: NCI CTRP-Clinical Trials Reporting Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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