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

NCT01675830 | Completed Phase 1 Results DMC

• 1 other identifier: IRB-P00001161
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Thermoregulation

Outcome Measures

Primary Outcomes (1)

• 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.

  <12 hours

Secondary Outcomes (1)

• 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.

Study Arms (1)

Head Retention Head Wrap device

EXPERIMENTAL

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

Interventions

Heat Retention Head Wrap DEVICE

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

Head Retention Head Wrap device

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cardiology Clinical Research & Regulatory Group: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Limitations and Caveats

Investigators could not account for differences in the room temperature, heated and humidified gases, CPB regulation, regulation of forced air warming system, warming of IV fluids, and temperature of irrigation solutions in the OR.

Results Point of Contact

• Title: Karen Sakakeeny
• Organization: Boston Children's Hospital

Karen.Sakakeeny@childrens.harvard.edu

617-355-6369

Study Officials

• Karen Sakakeeny, BSN

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: August 30, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 31, 2015
• Results First Posted: February 26, 2015

Record last verified: 2015-03

Locations

US (1)