Hyperthermic Intraperitoneal
Conditions
Brief 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.
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)
Interventions
DEVICEAllon 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
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer. | through HIPEC surgery (up to 4 hours) |
Countries
United States
Outcome results
None listed