Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass
Condition: Impaired Thermoregulation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I descriptive pilot study to determine the feasibility of using the Heat
      Retention Head Wrap on infants during the re-warming period following cardio-pulmonary
      bypass.
    

Detailed description: 
      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 Heat Retention 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 Heat Retention Head Wrap on infants during the re-warming period following CPB.

      Specific Aims

        1. To describe the feasibility of placing a Heat Retention 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 Heat Retention Head
           Wrap.
    

Intervention name(s): Heat Retention Head Wrap
Intervention type(s): Device
Intervention description(s): Applied to infant's heads during the rewarming phase of CBP surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention