Boston Children's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT01675830
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.
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Notify Me1 day–1 year
All sexes
Interventional
Phase 1
Boston, Massachusetts, 02115, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Applied to infant's heads during the rewarming phase of CBP surgery
Time frame: <12 hours
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. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.
Time frame: These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.
To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.
Cardiology Clinical Research & Regulatory Group
Other
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