Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys

NCT02032030 | Completed

• 1 other identifier: 201203088
• Study Type: observational
• Target: 73,952
• Locations: 1 country
• Sites: 1

Brief Summary

Based on limited published epidemiological data, up to an alarming 1 in 50 surgical inpatients die within 30 postoperative days. Based on our own data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials, 30-day postoperative mortality among high-risk surgical patients is comparable to this at Barnes-Jewish Hospital, and 1-year mortality among high-risk surgical patients may be as high as 10%. Short- and intermediate-term postoperative mortality is therefore a pressing public health concern. Similarly, postoperative major morbidity - including delirium, stroke, myocardial infarction, atrial fibrillation, blood clots, renal dysfunction, wound infection, pneumonia, respiratory failure, loss of functionality, and chronic pain - occurs commonly and affects a substantial proportion of surgical patients, critically ill patients and patients undergoing procedures for chronic pain. Many factors associate strongly and independently with postoperative mortality and major morbidity: patient age, functional status, comorbid medical conditions, and duration and invasiveness of surgery, among others. It is a strategic priority to identify pre- and intraoperative risk factors that are subject to modification.

Conditions

Heart Attack; Cardiac Arrest; Congestive Heart Failure; Atrial Fibrillation; Angina; Deep Vein Thrombosis; Pulmonary Embolism; Respiratory Arrest; Respiratory Failure; Pneumonia; Gastrointestinal Bleed; Stomach Ulcer; Delirium; Stroke; Nerve Injury; Surgical Wound Infection

Keywords

quality of Life; pain; nausea; falls; intraoperative awareness; anesthesia awareness; cognition; activities of daily living; major morbidity; all-cause mortality

Outcome Measures

Primary Outcomes (26)

• quality of life

  1 year

• functional health

  1 year

• falls

  1 year

• cognition

  1 year

• emotional health

  1 year

• mental health

  1 year

• physical health

  1 year

• pain

  1 year

• intraoperative awareness

  30-90 days

• all-cause mortality

  1 year

• surgical wound infection

  1 year

• nerve injury

  30-90 days

• stroke

  1 year

• delirium

  30-90days

• Stomach Ulcer

  30-90 days

• Gastrointestinal Bleed

  30-90 days

• Pneumonia

  1 year

• Respiratory Failure

  1 year

• Respiratory Arrest

  1 year

• Pulmonary Embolism

  1 year

• Deep Vein Thrombosis

  1 year

• Angina

  1 year

• Atrial Fibrillation

  1 year

• Congestive Heart Failure

  1 year

• Cardiac Arrest

  1 year

• Heart Attack

  1 year

Other Outcomes (1)

• Return to Work

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We are attempting to recruit all-comers visiting our preoperative assessment clinic, with current daily enrollment rates approaching 60%.

You may qualify if:

• Surgical and procedural patients who require anesthesia services

You may not qualify if:

• Patients under the age of 18 years

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (29)

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• Fritz BA, Escallier KE, Ben Abdallah A, Oberhaus J, Becker J, Geczi K, McKinnon S, Helsten DL, Sharma A, Wildes TS, Avidan MS. Convergent Validity of Three Methods for Measuring Postoperative Complications. Anesthesiology. 2016 Jun;124(6):1265-76. doi: 10.1097/ALN.0000000000001108.

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• Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.

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MeSH Terms

Conditions

Myocardial Infarction; Heart Arrest; Heart Failure; Atrial Fibrillation; Angina Pectoris; Venous Thrombosis; Pulmonary Embolism; Apnea; Respiratory Insufficiency; Pneumonia; Gastrointestinal Hemorrhage; Stomach Ulcer; Delirium; Stroke; Surgical Wound Infection; Pain; Nausea; Intraoperative Awareness

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac; Chest Pain; Neurologic Manifestations; Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Tract Infections; Infections; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Wound Infection; Postoperative Complications; Signs and Symptoms, Digestive; Intraoperative Complications

Study Officials

• Michael S Avidan, MBBCh, FCASA

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Anshuman Sharma, MD

  Washington University School of Medicine

  STUDY DIRECTOR

• Daniel Helsten, MD

  Washington University School of Medicine

  STUDY DIRECTOR

• Arbi Ben Abdallah, PhD

  Washington University School of Medicine

  STUDY DIRECTOR

• Troy Wildes, MD

  Washington University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute of Quality Improvement, Research & Informatics (INQUIRI)

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: July 1, 2012
• Primary Completion: October 1, 2020
• Study Completion: October 21, 2020
• Last Updated: August 9, 2022

Record last verified: 2022-06

Locations

US (1)