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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
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The accurate monitoring of physiological parameters in postoperative patients is essential for early detection and management of potential complications. One such critical parameter is the pH of abdominal drainage fluid, which can provide valuable insights into the patient's recovery and the presence of any postoperative infections or complications after gastrointestinal surgery. The Streamâ„¢ Platform, consisting of the Originâ„¢ inline biosensor system and supporting materials, represents a significant advancement in this area. Originâ„¢ is designed to be integrated inline with a standard surgical drain, enabling real-time monitoring of drainage effluent characteristics, specifically pH, which represents the acidity of the fluid.
This protocol details the analytical validation of the Streamâ„¢ Platform, focusing on the pH measurements conducted by the Originâ„¢ device. The study aims to establish the precision, linearity, and analytical specificity of the Originâ„¢ system. Additionally, method comparison studies will be conducted to evaluate the performance of the Originâ„¢ device against standard bench-top comparators.
The multi-center study will be conducted using commercially available calibration fluids and abdominal drainage samples collected from patients undergoing abdominal surgeries. These samples, which include those from colorectal, hepatobiliary, and trauma and acute care patients, will be utilized to validate the Originâ„¢ device's capability to deliver accurate and reliable pH measurements.
This is a multi-center study, being conducted to facilitate the Analytical Validation of Streamâ„¢ Platform. This includes precision evaluation assessing repeatability and reproducibility of the pH measurements conducted by Originâ„¢, tests evaluating the linearity of measurements, analytical specificity (interference testing), and method comparison studies. The tests described under this study will be completed using commercially available calibration fluids, and peritoneal drainage samples collected from patients that undergo gastrointestinal surgery. Simulated peritoneal fluids, adjusted to the required pH may be utilized in some cases. Additionally, peritoneal drainage samples may be used for testing, verification, and validation of novel Originâ„¢features, designed to improve user workflow. The following patient populations will be eligible for the collection of abdominal drainage samples: colorectal, hepatobiliary, and trauma and acute care patients.
This study will require collection of peritoneal drainage fluid of subjects that undergo gastrointestinal surgery. One sample will be collected per day and will be labelled with a study ID, date and time of collection, and then frozen. The sample will be supplied to FluidAI team. The team at FluidAI will conduct the laboratory assessments required for analytical validation of pH measurements of Originâ„¢.
This study does not pose any risk to participants as abdominal drainage fluid is routinely discarded as it is considered a waste product. No personal health information will be collected from the participants, and the study requires no follow up. Participation from subjects will be deemed complete when they are discharged from the hospital, or when their abdominal drain is removed as determined by their surgeon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sample Collection Cohort | This group will contain patients that undergo gastrointestinal surgeries, namely hepatobiliary, colorectal, trauma, and acute care procedures, and received an abdominal drain. Samples of abdominal drainage fluid will be collected daily from each patient. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal Drainage Fluid Collection | Other | Abdominal drainage fluid will be collected daily from the subjects until they are discharged from the hospital, or their abdominal/pelvic drain is removed, as determined by the treating surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| Conduct precision evaluation of pH measurements obtained using Originâ„¢ | The objective of these tests is to assess the ability of the Originâ„¢ to provide a measurement proportional to the measurand being quantified over a defined range of pH with acceptable levels of variance, such that the device meets predefined acceptance criteria for precision estimates. | 8 months |
| Evaluate the linearity of pH measurements obtained using Originâ„¢ | The objective of this test is to establish, verify and demonstrate the linear range of Originâ„¢ in measuring the pH of peritoneal fluid. | 8 months |
| Evaluate the Analytical Specificity of pH measurements obtained using Originâ„¢ | The objective of this test is to evaluate the effect of potential interfering substances on the clinical and analytical performance of the Originâ„¢ via paired difference testing. In the event of an interference effect a dose-response experiment will be conducted to determine the magnitude of interference as a function of interferent concentration. | 8 months |
| Conduct method comparison studies for measuring pH of abdominal drainage fluid | The objective of this test is to compare the pH measurements of abdominal drainage fluid using Originâ„¢ and a standard benchtop comparator. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Testing, verification of validation of new Originâ„¢ features | To utilize samples of abdominal drainage for testing, verification and validation of new features developed to optimize the user workflow of Originâ„¢ in hospitals. | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects included in this study will consist of several patient populations who have undergone abdominal surgery and received an abdominal drain. This includes colorectal, hepatobiliary, and trauma and acute care patients. All subjects must meet the inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Pablo Serrano, MD MPH FACS | Contact | (905) 521-2100 | 43872 | serrano@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr Pablo Serrano, MD MPH FACS | Juravinski Hospital - Hamilton Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Hospital | Recruiting | Hamilton | Ontario | L8V1C3 | Canada |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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This study will focus on the collection of abdominal drainage fluid from study subjects.
Subjects that undergo gastrointestinal surgery often receive a prophylactic intra-peritoneal or pelvic drain. This drain prevents buildup of fluid in the abdominal cavity after surgery. The fluid from the drain is collected in an evacuator. The fluid may be used in laboratory, or is typically discarded. This fluid will be collected daily in this study. The fluid may contain DNA.