Thermoregulation Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass

According to the World Health Organization a body temperature of 36-36.5 degrees Celsius is
mild hypothermia, 32-36 degrees Celsius is moderate hypothermia, and < 32 degrees Celsius is
severe hypothermia.1 Hypothermia can be a major postoperative problem for infants undergoing
cardio-pulmonary bypass (CPB) surgery. During CPB, patients are cooled to decrease
metabolism and protect myocardium and brain. When the repair is completed, the patient is
re-warmed as the temperature of blood in the bypass pump is gradually increased. However,
after separation from the CBP pump, infants consistently experience a temperature drop of 2
to 5 degrees Celsius.

With head cooling heat dissipates more quickly than with any other body surface. As much as
60% of an infant's body heat can dissipate through an uncovered head, thus leaving patients
at high risk for complications associated with hypothermia. The amount of heat lost to the
environment by newborn infants has a great impact on mortality rates, growth, and energy
maintenance. Major adverse effects from inadvertent hypothermia include myocardial ischemia,
impaired coagulation, prolonged healing, surgical wound infections, and decreased
postoperative comfort.

Nursing participation in the re-warming of patients during CPB surgery is a core
intervention. According to recommendations for perioperative registered nurses the patient
should be at or returning to normothermia at the conclusion of the immediate postoperative
period. Current standards of care for re-warming after CPB do not include any particular
type of head covering. Recently, a new head covering made of biaxial-oriented polyethylene
terephthalate (boPET), called the Thermoregulation Head Wrap, has been designed for use with
infants to facilitate warming during the postoperative period (that begins during the
re-warming phase of CBP). The purpose of this study will be to determine the feasibility of
using the Thermoregulation Head Wrap on infants during the re-warming period following CPB.

Specific Aims

1. To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's
head from the time the re-warming process begins to the time baby arrives in the
Cardiac Intensive Care Unit (CICU) after transfer from the operating room.

2. To characterize the temperature progression from (1) the onset of re-warming, (2)
removal of bypass cannulas, to (3) removal of the rectal temperature probe immediately
before transfer from the OR to the CICU, and (4) upon arrival to the CICU.

3. To identify and describe adverse events observed with use of the Thermoregulation Head
Wrap.

Inclusion Criteria:

- Undergoing CPB surgery.

- Weigh ≥ 3 and ≤ 10 kg.

- Cooled to 24-30 degrees Celsius.

- Head circumferences between 33-48 cm.

- Scalp free of skin lesions such as reddened areas, ulcerations, abrasions, burns,
and hemangiomas.

Exclusion Criteria:

- Require cooling below 24 degrees Celsius at any point during CPB surgery.

- Weigh less than 3 kg or more than that 10kg.

- Are premature or < 37 weeks corrected gestational age.

- Have a head circumference smaller than 33 cm or larger than 48 cm.

- Have a known or previously diagnosed neurological trauma, malignant hyperthermia,
stroke, seizure, VP shunt, evidence of scalp lesions, or other known comorbidity.

- Have hair braided close to the scalp.

- Infants with known allergy or sensitivity to polyethylene terephthalate (known as
Mylar)