This trial is active, not recruiting.

Condition anesthesia
Sponsor Children's Hospital Medical Center, Cincinnati
Start date September 2007
End date March 2012
Trial size 16000 participants
Trial identifier NCT01871051, 2012-4414


This project was aimed to identify the risk factors associated with the occurrence of respiratory complications in post anesthesia care unit. The primary outcome was the composite measure of occurrence of complications in PACU. The components were apnea or hypopnea, laryngospasm, bronchospasm and prolonged oxygen requirement.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective

Primary Outcomes

Occurrence of complications in PACU
time frame: 4 years

Secondary Outcomes

Improve the quality of care for children undergoing anesthesia
time frame: 4 years

Eligibility Criteria

Male or female participants up to 18 years old.

Inclusion Criteria: 1) All patients who receive an anesthetic in participating institutions who are under 18 years of age and where an anesthetic record is generated will be included in the overall statistics for each center - Exclusion Criteria: 1) Patients older than 18 years of age.-

Additional Information

Official title Risk Factors For Postoperative Respiratory Complications After Anesthesia
Description This is a retrospective project. Data will be used from Quality Improvement database for publication purpose. Data was collected from a prospectively collected database that was done as a Quality Improvement Project. The study sites included post anesthesia care units (PACU) of the main and ambulatory campuses of our hospital. The data was collected from surgical and radiology PACU's. Data was collected each quarter for 2 weeks in the surgical PACU, and for 1 month in Radiology PACU, from Sep 2007 through Mar 2012. Trained perioperative nurses and Certified Registered Nurse Anesthesiologist did data collection. This ensured a sample representative of at least 10% of patients anesthetized for surgical and radiological procedures. The independent variables (risk factors) collected included age, American Society of Anesthesiology (ASA) physical status, obesity, preexisting airway or lung disease, preexisting neuromuscular disease or hypotonia, morbid obesity, intraoperative bronchospasm and intraoperative laryngospasm. The primary outcome variables collected were Apnea or hypopnea, Laryngospasm, Bronchospasm, and prolonged Oxygen requirement. Apnea or hypopnea was defined by the need for bag mask ventilation, Laryngospasm by the requirement of a positive pressure ventilation of > 20 cmH2O or administration of succinylcholine, Bronchospasm by use of albuterol, and Oxygen requirement by continued oxygen administration to maintain SpO2>92% for 2 hours postoperatively.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.