Risk Factors For Postoperative Respiratory Complications After Anesthesia

Anesthesia Clinical Trial

Official title:

Risk Factors For Postoperative Respiratory Complications After Anesthesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01871051
• Other study ID #: 2012-4414
• Status: Active, not recruiting
• Phase: N/A
• First received: June 4, 2013
• Last updated: June 4, 2013
• Start date: September 2007
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16000
• Est. completion date: December 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.-

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of complications in PACU	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.	4 years	No
Secondary	Improve the quality of care for children undergoing anesthesia	To improve the quality of care for children undergoing anesthesia in the United States by identifying preventable causes of anesthesia and surgery-related adverse events.; To use root cause analysis to investigate significant adverse events.	4 years	No