Impaired Thermoregulation
Conditions
Brief 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.
Interventions
DEVICEHeat Retention Head Wrap
Applied to infant's heads during the rewarming phase of CBP surgery
Sponsors
Cardiology Clinical Research & Regulatory Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Head Wrap Feasibility | <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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Head Wrap Device Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Head Wrap Device |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 17.4 weeks |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Head Wrap Feasibility
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: <12 hours
Population: Percentage of respondents that agree device is easy to use
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Head Wrap Device | Head Wrap Feasibility | 100 percentage of respondents |
Secondary
Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use
To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.
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.
Population: Number of adverse events observed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Head Wrap Device | Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use | 0 adverse events |