Postoperative Respiratory Abnormalities

Respiratory Failure Clinical Trial

— AI-ARF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04079829
• Other study ID #: ARF-Retrospective Cohort
• Secondary ID: HSC-MH-19-0525
• Status: Active, not recruiting
• Start date: September 1, 2019
• Est. completion date: October 2020

Study information

• Verified date: June 2020
• Source: Efficacy Care R&D Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50000
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cardiac Failure
• Acute Kidney Failure
• Acute Kidney Injury
• Acute Respiratory Decompensation
• Acute Respiratory Failure
• Acute Respiratory Failure Following Trauma and Surgery
• Acute Respiratory Failure Post Surgical
• Acute Respiratory Failure Post Traumatic
• Acute Respiratory Failure Postprocedural
• Acute Respiratory Failure Requiring Reintubation
• Acute Respiratory Failure With Hypercapnia
• Acute Respiratory Failure With Hypoxia
• Apnea
• Heart Failure
• Hypercapnia
• Hypoxia
• Multi Organ Failure
• Multiple Organ Failure
• Renal Insufficiency
• Respiratory Arrest
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Shock
• Shock, Cardiogenic
• Shock, Septic

Intervention

Other:
• Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data
No interventions

Locations

Country	Name	City	State
United States	Memorial Hermann Medical Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Efficacy Care R&D Ltd	CRG Medical, Inc., Memorial Hermann Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length- of-Stay	Unplanned ICU Length- of-Stay (LOS)	30 days
Secondary	Inpatient mortality overall		30 days
Secondary	The incremental cost-effectiveness ratio (ICER)		30 days
Secondary	30-day readmission		30 days
Secondary	30-day hospital mortality		30 days
Secondary	time to event		30 days