- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01871051
Risk Factors For Postoperative Respiratory Complications After Anesthesia
June 4, 2013 updated by: Children's Hospital Medical Center, Cincinnati
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.
Study Overview
Status
Unknown
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
16000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of complications in PACU
Time Frame: 4 years
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improve the quality of care for children undergoing anesthesia
Time Frame: 4 years
|
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
March 1, 2012
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
June 4, 2013
First Submitted That Met QC Criteria
June 4, 2013
First Posted (Estimate)
June 6, 2013
Study Record Updates
Last Update Posted (Estimate)
June 6, 2013
Last Update Submitted That Met QC Criteria
June 4, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 2012-4414
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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