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| ID | Type | Description | Link |
|---|---|---|---|
| HSC-MH-19-0525 | Other Identifier | The Committee for the Protection of Human Subjects(CPHS) |
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| Name | Class |
|---|---|
| Memorial Hermann Hospital | OTHER |
| CRG Medical, Inc. | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data | Other | No interventions |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length- of-Stay | Unplanned ICU Length- of-Stay (LOS) | 30 days |
| Inpatient mortality overall | 30 days | |
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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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Paul G Loubser, MD | Memorial Hermann | Principal Investigator |
| Nadav Lankin | Efficacy Care R&D Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Medical Center | Houston | Texas | 77024 | United States |
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| The incremental cost-effectiveness ratio (ICER) |
| 30 days |
| 30-day readmission | 30 days |
| 30-day hospital mortality | 30 days |
| time to event | 30 days |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D001049 | Apnea |
| D012128 | Respiratory Distress Syndrome |
| D012769 | Shock |
| D012772 | Shock, Septic |
| D012770 | Shock, Cardiogenic |
| D009102 | Multiple Organ Failure |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D010335 | Pathologic Processes |
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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