Postoperative Respiratory Abnormalities (AI-ARF)

Data Completeness and Analysis of Underlying Systems Factors in a Retrospective Cohort - Postoperative Respiratory Abnormalities

The study aims to determine how historical cases of respiratory abnormalities are documented by clinicians in the electronic health records (EHR) of Memorial Hermann Healthcare System (MHHS) inpatient facilities. The knowledge gained from this study will support the design of modern data-driven surveillance approach to continuously collect, monitor and timely recognize postoperative respiratory abnormalities using electronic healthcare recorded data.

Study Overview

• Status: Unknown
• Conditions: Shock; Shock, Septic; Respiratory Failure; Respiratory Distress Syndrome; Shock, Cardiogenic; Acute Cardiac Failure; Acute Respiratory Failure; Acute Kidney Failure; Multi Organ Failure; Respiratory Arrest; Acute Respiratory Failure With Hypoxia; Acute Respiratory Failure Requiring Reintubation; Acute Respiratory Failure With Hypercapnia; Acute Respiratory Failure Post Surgical; Acute Respiratory Failure Postprocedural; Acute Respiratory Failure Following Trauma and Surgery; Acute Respiratory Failure Post Traumatic; Acute Respiratory Decompensation
• Intervention / Treatment: Other: Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data

Detailed Description

• Currently available studies are not clear about avoidable risk factors as actionable tools to reduce patient deterioration triggered by respiratory complications. The lack of this crucial knowledge leads to errors in further cases, and errors in medical documentation leads to limited learning from errors and potentially preventable harm to patients.
• The respiratory measurement is an early indicator of disease, yet many clinicians underestimate its importance and hospitals report a poor level of respiratory rate recordings. As respiratory abnormalities are early markers of patient deterioration, it is hoped that improved and continued data collection and monitoring will have an impact on the nature and timeliness of the response to critical illness. Data concordance plays a major role in documentation quality, especially for data-mining and knowledge extraction analysis, therefore it is essential to address the reliability of 'respiratory abnormalities' labelled data within the Electronic Health Record (EHR) system.
• It is hypothesized that an exploratory analysis of historical medical records by using an advanced algorithm could reveal novel and improved knowledge about the nature of Respiratory Abnormalities. However, the quality, computability, reliability, accuracy and completeness of the data are questionable.
• It's also hypothesized that efficacious and preventive intervention can reduce the increased burden of illness followed by respiratory abnormalities, reduce the enormous number of treatable incidences and be cost-effective when delivered in the real-life clinical environment.

• Study Type: Observational
• Enrollment (Anticipated): 50000

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77024
      • Memorial Hermann Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sample Size: 50,000 Gender: M - 25,000; F - 25000 approx. Age: 18 and older General Health Status: Respiratory Abnormalities

Total Number of Subjects Projected: It is expected that approximately 75,000 subjects will be enrolled (identified for further review) to produce 50,000 evaluable subjects.

Description

Inclusion Criteria:

The study aims to investigate patient records for all postoperative patients aged 18 years and older undergoing unplanned admission to an intensive care unit (ICU).

Criteria to be Met (ASA = American Society of Anesthesiology Class) Age greater than 18 years old on admission; ASA 1: A normal healthy patient; or ASA 2: A patient with a mild systemic disease; or ASA 3: A patient with a severe systemic disease that is not life-threatening; or ASA 4: A patient with a severe systemic disease that is a constant threat to life; or

Major complication associated with either operating room procedure or anesthesia. Example: Cardiac or circulatory event and/or Cardiac arrest during or within 24 hours of operation or administration of anesthesia; or Acute myocardial infarction (AMI) during or within 48 hours of operation or administration of anesthesia; or Central nervous system event (e.g., CVA, seizures, coma) during or within 48 hours of operation or administration of anesthesia; or Respiratory failure not present prior to the 25th hour of hospitalization or not present before surgery; or

Whichever is earlier, indicated by any of:

the reinstitution of ventilator support following discontinuance after operation; or Continuous ventilator support for more than 7 days following operation; or use of a ventilator postoperatively only.

Exclusion Criteria:

Patient records who are under 18 years of age;

Any surgical or invasive procedure performed as an emergency; or Respiratory abnormality present on admission; ASA 5: A moribund patient who is not expected to survive without the operation. The patient is not expected to survive beyond the next 24 hours without surgery.

ASA 6: A brain-dead patient whose organs are being removed with the intention of transplanting them into another patient.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative respiratory abnormalities	The primary outcomes measured in this study are the number of cases determining the presence, absence, or likelihood of subsequent development of postoperative respiratory abnormalities.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length- of-Stay	Unplanned ICU Length- of-Stay (LOS)	30 days
Inpatient mortality overall		30 days
The incremental cost-effectiveness ratio (ICER)		30 days
30-day readmission		30 days
30-day hospital mortality		30 days
time to event		30 days

Collaborators and Investigators

• Sponsor: Efficacy Care R&D Ltd
• Collaborators: Memorial Hermann Hospital; CRG Medical, Inc.
• Investigators: Principal Investigator: Paul G Loubser, MD, Memorial Hermann; Principal Investigator: Nadav Lankin, Efficacy Care R&D Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Signs and Symptoms, Respiratory; Myocardial Infarction; Infarction; Infant, Premature, Diseases; Heart Failure; Shock, Septic; Respiratory Insufficiency; Shock; Renal Insufficiency; Acute Kidney Injury; Hypoxia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Shock, Cardiogenic; Hypercapnia; Multiple Organ Failure
• Other Study ID Numbers: ARF-Retrospective Cohort; HSC-MH-19-0525 (Other Identifier: The Committee for the Protection of Human Subjects(CPHS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No