Craniofacial Surgery Perioperative Registry

This study has been completed.
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00658242
First received: April 8, 2008
Last updated: December 13, 2012
Last verified: December 2012

April 8, 2008
December 13, 2012
March 2008
June 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00658242 on ClinicalTrials.gov Archive Site
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Craniofacial Surgery Perioperative Registry
Craniofacial Surgery Perioperative Registry

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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Subjects presenting for craniofacial surgery

Craniotomy
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I
Subjects having Craniofacial surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00658242
2008-3-5842
No
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Principal Investigator: Paul A Stricker, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP