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

• ClinicalTrials.gov Identifier: NCT01675830
• Recruitment Status: Completed
• First Posted: August 30, 2012
• Results First Posted: February 26, 2015
• Last Update Posted: March 31, 2015
• Sponsor: Cardiology Clinical Research & Regulatory Group
• Information provided by (Responsible Party): Cardiology Clinical Research & Regulatory Group

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Impaired Thermoregulation	Device: Heat Retention Head Wrap	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass
• Study Start Date: November 2011
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Head Retention Head Wrap device; All subjects recieved the experimental intervention with the Heat Retention Head Wrap device for during the rewarming phase of cardiopulmonary bypass surgery.	Device: Heat Retention Head Wrap; Applied to infant's heads during the rewarming phase of CBP surgery

Outcome Measures

Primary Outcome Measures :

1. Head Wrap Feasibility [ 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.

Secondary Outcome Measures :

1. Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use [ 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.

Eligibility Criteria

• Ages Eligible for Study: up to 1 Year (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Cardiology Clinical Research & Regulatory Group

Investigators

• Principal Investigator: Karen Sakakeeny, BSN; Boston Children's Hospital

More Information

• Responsible Party: Cardiology Clinical Research & Regulatory Group
• ClinicalTrials.gov Identifier: NCT01675830
• Other Study ID Numbers: IRB-P00001161
• First Posted: August 30, 2012
• Results First Posted: February 26, 2015
• Last Update Posted: March 31, 2015
• Last Verified: March 2015