Postoperative Respiratory Abnormalities

NCT04079829 | Unknown DMC

• 2 other identifiers: ARF-Retrospective CohortHSC-MH-19-0525
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Failure; Respiratory Arrest; Respiratory Distress Syndrome; Acute Respiratory Failure; Acute Respiratory Failure With Hypoxia; Acute Respiratory Failure With Hypercapnia; Acute Respiratory Failure Post Surgical; Acute Respiratory Failure Postprocedural; Acute Respiratory Failure Following Trauma and Surgery; Acute Respiratory Failure Requiring Reintubation; Acute Respiratory Failure Post Traumatic; Acute Respiratory Decompensation; Shock; Shock, Septic; Shock, Cardiogenic; Acute Cardiac Failure; Multi Organ Failure; Acute Kidney Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Length- of-Stay

  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

Interventions

Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data OTHER

No interventions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Efficacy Care R&D Ltd: lead
• Memorial Hermann Hospital: collaborator
• CRG Medical, Inc.: collaborator

Study Sites (1)

Memorial Hermann Medical Center

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Apnea; Respiratory Distress Syndrome; Shock; Shock, Septic; Shock, Cardiogenic; Multiple Organ Failure; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Pathologic Processes; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Paul G Loubser, MD

  Memorial Hermann

  PRINCIPAL INVESTIGATOR

• Nadav Lankin

  Efficacy Care R&D Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: September 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: June 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)