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Craniofacial Surgery Perioperative Registry

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ClinicalTrials.gov Identifier: NCT00658242
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : August 9, 2013
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
Craniofacial reconstruction procedures are undertaken in young children to improve appearance, prevent functional disturbances, and enhance psychosocial development. These procedures involve wide scalp dissections and multiple osteotomies and have been associated with significant morbidity. The most commonly seen perioperative complications are associated with the rate and extent of blood loss. This prospective observational registry will be a research tool which will provide a means to evaluate perioperative management of these children at CHOP.

Condition or disease
Craniotomy

Detailed Description:
Craniofacial reconstructive surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. These procedures are undertaken in young children to improve appearance, prevent functional disturbances, and enhance psychosocial development. The surgery is extensive, often requiring wide scalp dissections and multiple osteotomies and has been associated with significant morbidity. Reported complications include intra-operative cardiac arrest, massive blood loss, intraoperative tracheal extubation, venous air embolism, hypotension, coagulopathy, bradycardia, postoperative seizures, surgical site infections, facial swelling, and unplanned postoperative mechanical ventilation. The most severe and commonly seen problems are associated with the rate and extent of blood loss. Studies report estimated blood loss to average between 60% and 100% of the patient's estimated blood volume, with a range of 20-500%.(Hildebrandt et al 2007) The accurate and timely estimation of blood loss is very difficult and results in imprecise quantitative and qualitative replacement. Clinically important hypotension, metabolic acidosis, anemia, polycythemia, dilutional coagulopathy, cardiac arrest, and death are all related to blood loss. The creation of this prospective observational registry will provide a means to describe the incidence of these and other clinically important perioperative problems.

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Study Type : Observational
Actual Enrollment : 249 participants
Time Perspective: Prospective
Official Title: Craniofacial Surgery Perioperative Registry
Study Start Date : March 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Group/Cohort
I
Subjects having Craniofacial surgery



Primary Outcome Measures :
  1. To create a research tool that prospectively captures perioperative data in the craniofacial surgical patient population that may provide insights into the perioperative management and help guide clinical decision making. [ Time Frame: 2.5 years ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects presenting for craniofacial surgery
Criteria

Inclusion Criteria:

  1. Males or females with ages from birth to 18 years.
  2. Patients undergoing surgical procedures on the craniofacial region performed by plastic surgeons, neurosurgeons, or by plastic surgeons in concert with neurosurgeons.
  3. Patients undergoing plastic surgical procedures involving a craniotomy, craniectomy, maxillofacial osteotomy, strip craniectomy, or other plastic surgical procedure involving bones of the head and face.
  4. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

  1. Patients undergoing craniofacial plastic surgical procedures not involving bones of the head and face.
  2. Patients not admitted to the intensive care unit following surgery.
  3. Patients undergoing procedures only involving the mandible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658242


Locations
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United States, Pennsylvania
The Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Investigators
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Principal Investigator: Paul A Stricker, MD Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00658242     History of Changes
Other Study ID Numbers: 2008-3-5842
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013
Keywords provided by Children's Hospital of Philadelphia:
craniofacial
maxillofacial
osteotomy
craniectomy
craniotomy