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OpenTrials
Completed

NCT Number: NCT01871051

Risk Factors For Postoperative Respiratory Complications After Anesthesia

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.

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Key information

Conditions

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Patients older than 18 years of age.-

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Improve the quality of care for children undergoing anesthesia

    Time frame: 4 years

    • 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Jun 6, 2013
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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