Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597253
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
A Single-centre Study Comparing a Non-invasive Lactate Sensor to Standard Invasive Measurements in Patients Undergoing Coronary Artery Bypass Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Centre Study Comparing a Continuous Non-invasive Lactate Sensor Measurement to Standard Invasive Measurements of Venous and Arterial Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft - Valve Surgery
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 L
Brief Summary:
The main goal of this study is to see how well a non-invasive lactate sensor measures lactate levels compared to standard blood tests This might reduce the need for frequent blood draws during surgery recovery and also provide a more comfortable experience for patients This will also give us information regarding the suitability of the lactate sensor for monitoring other patients - for instance people attending the accident and emergency department with chest pain in which lactate levels may help make a quick diagnosis
Patients will be approached for this study if they are undergoing routine coronary artery bypass surgery CABG or valve replacement surgery Participants will wear the non-invasive lactate sensor for up to 14 hours and the readings will be correlated to lactate levels in blood samples Once the sensor has been removed and the participant has been discharged from their elective surgery admission the participant has completed the study
Participation in this study and the data collected from the sensor will help us understand how well it works and how it can be used to improve patient care in the future
In the future the data from this new device will be used to train computer algorithms to provide quick responses that could help manage a patients condition improving future medical care
Patients will be approached for this study if they are undergoing routine coronary artery bypass surgery CABG or valve replacement surgery Participants will wear the non-invasive lactate sensor for up to 14 hours and the readings will be correlated to lactate levels in blood samples Once the sensor has been removed and the participant has been discharged from their elective surgery admission the participant has completed the study
Participation in this study and the data collected from the sensor will help us understand how well it works and how it can be used to improve patient care in the future
In the future the data from this new device will be used to train computer algorithms to provide quick responses that could help manage a patients condition improving future medical care
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 patients direct care team will look at the records for patients who are attending St Bartholomews hospital for cardiac surgery for grafts and or valve replacement
Informed Consent If the patient is eligible and wishes to participate in the study a qualified individual from the research team will obtain their consent If the person obtaining the consent is not a doctor the participant will be given the opportunity to discuss the study with a medically qualified individual
Screening The research nurse or doctor will collect demographic information from the patient and ensure the patient meets the studys inclusion and exclusion criteria
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 and or replacement valve surgery If the patient agrees to additional blood samples they will also have samples collected for sex hormone levels
CABG - replacement valve surgery The patient will then undergo their planned coronary artery bypass graft CABG - replacement valve surgery as usual
Sensor Application After surgery when the patient is settled in Cardiac Intensive Care Unit the research nurse will place a lactate sensor on the patients arm This sensor will continuously measure the patients lactate levels The patient may be asleep whilst the sensor is attached
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 If the patient agrees to additional blood samples they will also have 6 samples collected for inflammatory profiles and 3 for full blood counts
Sensor Removal After 14 hours the sensor 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 patients direct care team will look at the records for patients who are attending St Bartholomews hospital for cardiac surgery for grafts and or valve replacement
Informed Consent If the patient is eligible and wishes to participate in the study a qualified individual from the research team will obtain their consent If the person obtaining the consent is not a doctor the participant will be given the opportunity to discuss the study with a medically qualified individual
Screening The research nurse or doctor will collect demographic information from the patient and ensure the patient meets the studys inclusion and exclusion criteria
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 and or replacement valve surgery If the patient agrees to additional blood samples they will also have samples collected for sex hormone levels
CABG - replacement valve surgery The patient will then undergo their planned coronary artery bypass graft CABG - replacement valve surgery as usual
Sensor Application After surgery when the patient is settled in Cardiac Intensive Care Unit the research nurse will place a lactate sensor on the patients arm This sensor will continuously measure the patients lactate levels The patient may be asleep whilst the sensor is attached
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 If the patient agrees to additional blood samples they will also have 6 samples collected for inflammatory profiles and 3 for full blood counts
Sensor Removal After 14 hours the sensor 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