Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602336
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection to Standard Measurements of Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery andor Valve Replacement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection as Measured by Change in Current to Standard Measurements of Change in Venous and Arterial Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery andor Valve Replacement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTINUUM LINT
Brief Summary:
The main goal of this study is to see if a wearable device can reliably track changes in lactate levels in the body Weamp39ll compare the deviceamp39s readings to standard blood tests to ensure accuracy If successful this device could reduce the need for frequent blood tests during surgery recovery making patients more comfortable It might also be useful in emergency rooms for quick diagnoses especially for patients with chest pain
This study will take place at Barts Hospital with patients having planned coronary artery bypass graft CABG andor replacement valve surgery Participants will wear the sensors on their upper arm during which the sensors will continuously measure lactate levels Participants will also have hourly blood samples taken
In the future the data from this new device will be used to train computer algorithms to provide quick responses that help manage a patientamp39s condition improving future medical care and technology
This study will take place at Barts Hospital with patients having planned coronary artery bypass graft CABG andor replacement valve surgery Participants will wear the sensors on their upper arm during which the sensors will continuously measure lactate levels Participants will also have hourly blood samples taken
In the future the data from this new device will be used to train computer algorithms to provide quick responses that help manage a patientamp39s condition improving future medical care and technology
Detailed Description:
Summary of the study design and methodology
The research nurse or doctor will meet with the patient to explain the study and check the following
Pre-screening The research nurse who may also be part of the patient39s direct care team will look at the records for patients who are attending St Bartholomews hospital for cardiac surgery for grafts andor valve replacement
Informed Consent If the patient is eligible and would like to take part in the study the research nurse or doctor will ask the patient to sign a consent form indicating their willingness to participate in the study
Screening The research nurse or doctor will collect demographic information from the patient and ensure the patient meets the studys inclusion and exclusion criteria
Sensor Application Up to 5 days pre-surgery the research nurse will place two lactate sensors on the patients arm The sensor has a 24 hour warm-up period prior to continuously measuring the patients lactate levels
Pre-Surgery Admission The research nurse will gather details about the patients medical history and current medications The patient will have their blood pressure heart rate respiratory rate weight and height measured and an ECG performed Baseline blood samples will be collected as per the standard of care pre-CABG andor valve surgery
CABG andor replacement valve surgery The patient will then undergo their planned CABG andor replacement valve surgery as usual
Blood Sampling The patient will have hourly blood samples taken through the tubes inserted for their surgery for up to 14 hours to compare with the sensor readings These samples will include 12 arterial lactate 12 central venous lactate and 12 venous troponin samples Hourly measurements of the patients blood pressure heart rate and respiratory rate will be taken and any medication changes will be noted
Sensor Removal Up to 48 hours post-surgery the sensors will be removed and the patients skin will be checked for any changes like a rash The patient will also have their blood pressure heart rate and respiratory rate measured and an ECG performed Any changes to the patients medication will be noted
Follow-Up The study team will monitor the patient for up to 24 hours after the sensor is removed or until the patient is discharged from the hospital whichever is earlier The study team will note any medication changes measure the patients blood pressure heart rate and respiratory rate and perform an ECG
The research nurse or doctor will meet with the patient to explain the study and check the following
Pre-screening The research nurse who may also be part of the patient39s direct care team will look at the records for patients who are attending St Bartholomews hospital for cardiac surgery for grafts andor valve replacement
Informed Consent If the patient is eligible and would like to take part in the study the research nurse or doctor will ask the patient to sign a consent form indicating their willingness to participate in the study
Screening The research nurse or doctor will collect demographic information from the patient and ensure the patient meets the studys inclusion and exclusion criteria
Sensor Application Up to 5 days pre-surgery the research nurse will place two lactate sensors on the patients arm The sensor has a 24 hour warm-up period prior to continuously measuring the patients lactate levels
Pre-Surgery Admission The research nurse will gather details about the patients medical history and current medications The patient will have their blood pressure heart rate respiratory rate weight and height measured and an ECG performed Baseline blood samples will be collected as per the standard of care pre-CABG andor valve surgery
CABG andor replacement valve surgery The patient will then undergo their planned CABG andor replacement valve surgery as usual
Blood Sampling The patient will have hourly blood samples taken through the tubes inserted for their surgery for up to 14 hours to compare with the sensor readings These samples will include 12 arterial lactate 12 central venous lactate and 12 venous troponin samples Hourly measurements of the patients blood pressure heart rate and respiratory rate will be taken and any medication changes will be noted
Sensor Removal Up to 48 hours post-surgery the sensors will be removed and the patients skin will be checked for any changes like a rash The patient will also have their blood pressure heart rate and respiratory rate measured and an ECG performed Any changes to the patients medication will be noted
Follow-Up The study team will monitor the patient for up to 24 hours after the sensor is removed or until the patient is discharged from the hospital whichever is earlier The study team will note any medication changes measure the patients blood pressure heart rate and respiratory rate and perform an ECG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None