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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2023-05-03

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Hyperthermic Intraperitoneal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Allon System

Intervention Type DEVICE

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

Interventions

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Allon System

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes