Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639737
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Preoperative Blood Volume Optimization Using Transthoracic Echocardiography
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Preoperative Stroke Volume Optimization Using Transthoracic Echocardiography on Arterial Hypotension Following Induction of Intravenous Anesthesia A Prospective Double Blinded Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
EchOptimal
Brief Summary:
Immediately following the induction of general anesthesia arterial hypotension may occur with an incidence of about 40 in patients classified as ASA 3 or 4 Perioperative arterial hypotension is associated with increased perioperative morbidity and mortality The increased mortality associated with perioperative arterial hypotension has been reported up to 30 and 90 days after surgery This association appears to be both dose-dependent and time-dependent severity and duration of arterial hypotension
EchOptimal study aims to determine whether non invasive preoperative stroke volume optimization using transthoracic echocardiography TTE can reduce the incidence and severity arterial hypotension following induction of general anesthesia
This is prospective randomized controlled double blinded study approved by ethics comittee
The primary objective of this study is to compare the incidence of arterial hypotension mean arterial pressure 65 mmHg within the first 15 minutes following the induction of general anesthesia between 2 groups
standard current care stroke volume optimized after induction of general anesthesia using oesophageal doppler and
preopertaive stroke volume optimization using transthoracic echocardiography measument of subaortic velocity time integral
EchOptimal study aims to determine whether non invasive preoperative stroke volume optimization using transthoracic echocardiography TTE can reduce the incidence and severity arterial hypotension following induction of general anesthesia
This is prospective randomized controlled double blinded study approved by ethics comittee
The primary objective of this study is to compare the incidence of arterial hypotension mean arterial pressure 65 mmHg within the first 15 minutes following the induction of general anesthesia between 2 groups
standard current care stroke volume optimized after induction of general anesthesia using oesophageal doppler and
preopertaive stroke volume optimization using transthoracic echocardiography measument of subaortic velocity time integral
Detailed Description:
The pre-inclusion visit consists of a preoperative evaluation of the patient in the emergency operating room This evaluation is conducted by an anesthesiologist for all patients requiring surgical care in the emergency operating room
This evaluation is structured similarly to a pre-anesthetic consultation conducted by an anesthesiologist for scheduled surgery During this preoperative evaluation the patients medical and surgical history current treatments and possible allergies are collected A targeted clinical examination is also performed
After this evaluation the anesthesiologist analyzes the risks posed by the patient and the specific risks associated with surgery and anesthesia to define the best perioperative strategy
Surgical interventions are classified into three categories of postoperative cardiovascular risk low intermediate or high for cardiovascular complications within 30 days post-surgery according to the table provided by French and European recommendations
During this consultation patients eligible for the study ASA classification 3 or 4 requiring general anesthesia for intermediate or high-risk surgery will be identified
After verifying the inclusionexclusion criteria the patient will be informed about the study its course objectives and constraints
An information letter will be given to the patient and their informed consent will be collected in writing
The pre-inclusion and inclusion visits will thus take place at the same time
2 Inclusion visit V0
This visit is conducted alongside the pre-inclusion visit
Verification of inclusionnon-inclusion criteria by the investigator
Patient information regarding the study its procedures constraints and foreseeable risks
Presentation of the information letter and obtaining of written informed consent after ensuring the patients full understanding of the proposed protocol and answering all questions
Collection of main medical history and concurrent treatments
Clinical examination with vital signs
Explanation of the study procedures
3 Practical implementation of the protocol - patient management
After inclusion as per paragraphs 1 and 2 above all patients will undergo standard perioperative monitoring
5-lead electrocardiogram IntelliVue MP 70 Philips HealthCare Amsterdam Netherlands
Pulse oximetry
Direct and continuous blood pressure measurement using a catheter inserted under local anesthesia into the radial artery right or left after verifying no contraindications The catheter will be connected to a pressure transducer calibrated at the fifth intercostal space at the mid-axillary line
Bispectral index BIS Quatro Sensor Covidien Dublin Ireland to monitor anesthesia depth keeping values within the recommended range between 45 and 55
Accelerometer Philips IntelliVue NMT Philips HealthCare Amsterdam Netherlands placed on the thumb opposite the continuous blood pressure measurement site to monitor the effects of neuromuscular blocking agents curare
Before entering the operating room in the recovery room of the emergency operating block the patients will undergo the following
Control group A transthoracic echocardiography TTE without volume optimization performed as recommended for preoperative evaluation of ventricular and valvular function This TTE will be carried out by an experienced operator independent of the patients care
Experimental group A TTE with volume optimization as explained earlier performed by an experienced operator independent of the patients care
For all patients the independent operator performing the TTE will share the collected data ventricular and valvular function with the anesthesiologist in charge of the patient This data which is important for patients with the included profile will be collected as recommended and documented in a standardized report in the anesthesia consultation software
In the operating room the patient management will follow best practices for anesthesia and intensive care based on the patient profile including
Comfortable patient positioning and warming using a forced-air warming blanket BairHugger 3M France Cergy-Pontoise France
Pre-oxygenation with a target expired O2 fraction above 90 before induction of general anesthesia
Induction of general anesthesia via intravenous injection using automated syringes with target-controlled anesthesia software with propofol and remifentanil The depth of anesthesia will be adjusted according to the bispectral index values
Administration of curare
Orotracheal intubation and mechanical ventilation following perioperative protective ventilation recommendations adapted to the patient FiO2 40 tidal volume 6-8 mLkg of ideal body weight PEEP
5 to 8 cmH2O
Insertion of the esophageal Doppler probe Cardio-Q Gamida Eaubonne France and urinary catheter
Volume optimization for both groups following current recommendations using stroke volume measurements from the esophageal Doppler and simultaneous measurement of the subaortic time-velocity integral ITVSAo with TTE
Throughout the induction of anesthesia and during the 15 minutes corresponding to the collection of the primary outcome an independent investigator not involved in patient care will record all the necessary data
4 Follow-up evaluations during the study V1 V2 etc No additional blood samples are required for this study A preoperative TTE called a preoperative screening FOCUS exam is proposed preoperatively for patients meeting the inclusion criteria of this study to evaluate their overall cardiac function before the intervention 15 Class IIB Level of Evidence B recommendation from the 2022 European Society of Cardiology guidelines on the assessment and management of patients undergoing non-cardiac surgery As a result the proportion of TTEs performed in addition compared to standard care will be minimal or none and can only be beneficial for preoperative assessment
However volume optimization is not routinely performed before the induction of general anesthesia as described earlier in the summary and context paragraphs This optimization does not require blood samples but involves a guided administration of crystalloids currently this administration is often empirical and not measured
The echocardiography machines used will be those already present in the operating room no additional equipment is required for this study
5 End-of-study evaluation The follow-up ends 15 minutes after the completion of general anesthesia induction
An analysis of all data between the start of induction and 15 minutes after the end of induction will be performed
6 Long-term follow-up evaluation No long-term follow-up evaluation
10 Data to be collected
All data recorded by the monitoring devices of a patient during general anesthesia will be noted This includes
Before the induction of general anesthesia
Data from the preoperative evaluation of the patient age weight height chronic conditions chronic treatments ASA classification operative indication systolic diastolic and mean blood pressure heart rate peripheral oxygen saturation
TTE data including the subaortic time-velocity integral ITVSAo
Data on the volume optimization performed in the experimental group volume of crystalloids administered type of crystalloid repeated measurements of ITVSAo blood pressure heart rate peripheral oxygen saturation
Time required for volume optimization from the placement of the echocardiography probe to the end of the last administration of crystalloids
During the induction of general anesthesia and for the 15 minutes following the initiation of controlled ventilation
Maximum cerebral targets for propofol and remifentanil used with the target-controlled intravenous anesthesia syringe
The highest and lowest systolic diastolic and mean blood pressure
Duration during which a blood pressure 65 mmHg is measured since the blood pressure is measured continuously this duration is assessed in 1-minute intervals
The highest and lowest respiratory variation in pulse pressure
The highest and lowest heart rate
The highest and lowest oxygen saturation
The highest and lowest expired CO2 levels
The highest lowest and average bispectral index over 15 minutes
Data from the volume optimization after the induction of general anesthesia obtained via esophageal Doppler stroke volume corrected ejection time peak velocity repeated measurements of blood pressure heart rate and peripheral oxygen saturation
Volume of crystalloids administered for volume optimization after induction
Vasopressor medications administered name and total doses
This evaluation is structured similarly to a pre-anesthetic consultation conducted by an anesthesiologist for scheduled surgery During this preoperative evaluation the patients medical and surgical history current treatments and possible allergies are collected A targeted clinical examination is also performed
After this evaluation the anesthesiologist analyzes the risks posed by the patient and the specific risks associated with surgery and anesthesia to define the best perioperative strategy
Surgical interventions are classified into three categories of postoperative cardiovascular risk low intermediate or high for cardiovascular complications within 30 days post-surgery according to the table provided by French and European recommendations
During this consultation patients eligible for the study ASA classification 3 or 4 requiring general anesthesia for intermediate or high-risk surgery will be identified
After verifying the inclusionexclusion criteria the patient will be informed about the study its course objectives and constraints
An information letter will be given to the patient and their informed consent will be collected in writing
The pre-inclusion and inclusion visits will thus take place at the same time
2 Inclusion visit V0
This visit is conducted alongside the pre-inclusion visit
Verification of inclusionnon-inclusion criteria by the investigator
Patient information regarding the study its procedures constraints and foreseeable risks
Presentation of the information letter and obtaining of written informed consent after ensuring the patients full understanding of the proposed protocol and answering all questions
Collection of main medical history and concurrent treatments
Clinical examination with vital signs
Explanation of the study procedures
3 Practical implementation of the protocol - patient management
After inclusion as per paragraphs 1 and 2 above all patients will undergo standard perioperative monitoring
5-lead electrocardiogram IntelliVue MP 70 Philips HealthCare Amsterdam Netherlands
Pulse oximetry
Direct and continuous blood pressure measurement using a catheter inserted under local anesthesia into the radial artery right or left after verifying no contraindications The catheter will be connected to a pressure transducer calibrated at the fifth intercostal space at the mid-axillary line
Bispectral index BIS Quatro Sensor Covidien Dublin Ireland to monitor anesthesia depth keeping values within the recommended range between 45 and 55
Accelerometer Philips IntelliVue NMT Philips HealthCare Amsterdam Netherlands placed on the thumb opposite the continuous blood pressure measurement site to monitor the effects of neuromuscular blocking agents curare
Before entering the operating room in the recovery room of the emergency operating block the patients will undergo the following
Control group A transthoracic echocardiography TTE without volume optimization performed as recommended for preoperative evaluation of ventricular and valvular function This TTE will be carried out by an experienced operator independent of the patients care
Experimental group A TTE with volume optimization as explained earlier performed by an experienced operator independent of the patients care
For all patients the independent operator performing the TTE will share the collected data ventricular and valvular function with the anesthesiologist in charge of the patient This data which is important for patients with the included profile will be collected as recommended and documented in a standardized report in the anesthesia consultation software
In the operating room the patient management will follow best practices for anesthesia and intensive care based on the patient profile including
Comfortable patient positioning and warming using a forced-air warming blanket BairHugger 3M France Cergy-Pontoise France
Pre-oxygenation with a target expired O2 fraction above 90 before induction of general anesthesia
Induction of general anesthesia via intravenous injection using automated syringes with target-controlled anesthesia software with propofol and remifentanil The depth of anesthesia will be adjusted according to the bispectral index values
Administration of curare
Orotracheal intubation and mechanical ventilation following perioperative protective ventilation recommendations adapted to the patient FiO2 40 tidal volume 6-8 mLkg of ideal body weight PEEP
5 to 8 cmH2O
Insertion of the esophageal Doppler probe Cardio-Q Gamida Eaubonne France and urinary catheter
Volume optimization for both groups following current recommendations using stroke volume measurements from the esophageal Doppler and simultaneous measurement of the subaortic time-velocity integral ITVSAo with TTE
Throughout the induction of anesthesia and during the 15 minutes corresponding to the collection of the primary outcome an independent investigator not involved in patient care will record all the necessary data
4 Follow-up evaluations during the study V1 V2 etc No additional blood samples are required for this study A preoperative TTE called a preoperative screening FOCUS exam is proposed preoperatively for patients meeting the inclusion criteria of this study to evaluate their overall cardiac function before the intervention 15 Class IIB Level of Evidence B recommendation from the 2022 European Society of Cardiology guidelines on the assessment and management of patients undergoing non-cardiac surgery As a result the proportion of TTEs performed in addition compared to standard care will be minimal or none and can only be beneficial for preoperative assessment
However volume optimization is not routinely performed before the induction of general anesthesia as described earlier in the summary and context paragraphs This optimization does not require blood samples but involves a guided administration of crystalloids currently this administration is often empirical and not measured
The echocardiography machines used will be those already present in the operating room no additional equipment is required for this study
5 End-of-study evaluation The follow-up ends 15 minutes after the completion of general anesthesia induction
An analysis of all data between the start of induction and 15 minutes after the end of induction will be performed
6 Long-term follow-up evaluation No long-term follow-up evaluation
10 Data to be collected
All data recorded by the monitoring devices of a patient during general anesthesia will be noted This includes
Before the induction of general anesthesia
Data from the preoperative evaluation of the patient age weight height chronic conditions chronic treatments ASA classification operative indication systolic diastolic and mean blood pressure heart rate peripheral oxygen saturation
TTE data including the subaortic time-velocity integral ITVSAo
Data on the volume optimization performed in the experimental group volume of crystalloids administered type of crystalloid repeated measurements of ITVSAo blood pressure heart rate peripheral oxygen saturation
Time required for volume optimization from the placement of the echocardiography probe to the end of the last administration of crystalloids
During the induction of general anesthesia and for the 15 minutes following the initiation of controlled ventilation
Maximum cerebral targets for propofol and remifentanil used with the target-controlled intravenous anesthesia syringe
The highest and lowest systolic diastolic and mean blood pressure
Duration during which a blood pressure 65 mmHg is measured since the blood pressure is measured continuously this duration is assessed in 1-minute intervals
The highest and lowest respiratory variation in pulse pressure
The highest and lowest heart rate
The highest and lowest oxygen saturation
The highest and lowest expired CO2 levels
The highest lowest and average bispectral index over 15 minutes
Data from the volume optimization after the induction of general anesthesia obtained via esophageal Doppler stroke volume corrected ejection time peak velocity repeated measurements of blood pressure heart rate and peripheral oxygen saturation
Volume of crystalloids administered for volume optimization after induction
Vasopressor medications administered name and total doses
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