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

NCT ID: NCT01675830

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-03-31

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.

Conditions

Impaired Thermoregulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Heat Retention Head Wrap

Intervention Type: DEVICE

Applied to infant's heads during the rewarming phase of CBP surgery

Interventions

Heat Retention Head Wrap

Applied to infant's heads during the rewarming phase of CBP surgery

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiology Clinical Research & Regulatory Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Sakakeeny, BSN

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-P00001161

Identifier Type: -

Identifier Source: org_study_id