Clinical trial NCT00658242: Craniofacial Surgery Perioperative Registry
Official title: Craniofacial Surgery Perioperative Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniotomy
Keywords: craniofacial
maxillofacial
osteotomy
craniectomy
craniotomy
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Children's Anesthesiology Associates, Ltd.
First posted: 2008-04-14
Enrollment: 249
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting for craniofacial surgery

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.

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital Of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Paul A Stricker, MD
role: PRINCIPAL_INVESTIGATOR
References: