Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06011187
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-08-21
Brief Title:
Assisted Fluid Management AFM System and Postoperative Outcome After High-risk Abdominal Surgery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Personalized Fluid Administration Using an AFM System for Goal Directed Fluid Therapy on Postoperative Outcome in High-risk Patients Undergoing High-risk Abdominal Surgery A Multicenter Stepped-wedge Cluster-randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEFLA
Brief Summary:
Goal directed fluid therapy GDFT or Personalized fluid therapy may benefit high-risk surgical patients but these strategies are infrequently implemented It has also been shown that without any goal or protocol for fluid resuscitation large inter- and intra-provider variability exist that have been correlated with poor patient outcomes
Recently an Assisted Fluid Management AFM system has been developed to help ease some of the work associated with GDFT protocol implementation The AFM system may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers This artificial intelligence-based system can suggest administration of fluid boluses analyse the hemodynamic effects of the bolus and continually re-assess the patient for further fluid requirements
To date there are no large outcome study using this AFM system The primary objective of this trial is thus to evaluate the impact of this AFM system to guide fluid bolus administration on a composite of major postoperative complications in high-risk patients undergoing high-risk abdominal surgery
Recently an Assisted Fluid Management AFM system has been developed to help ease some of the work associated with GDFT protocol implementation The AFM system may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers This artificial intelligence-based system can suggest administration of fluid boluses analyse the hemodynamic effects of the bolus and continually re-assess the patient for further fluid requirements
To date there are no large outcome study using this AFM system The primary objective of this trial is thus to evaluate the impact of this AFM system to guide fluid bolus administration on a composite of major postoperative complications in high-risk patients undergoing high-risk abdominal surgery
Detailed Description:
Many trials have indicated that goal-directed fluid therapy GDFT strategies or more recently personalized fluid therapy may benefit high-risk surgical patients but these strategies are infrequently implemented It has also been shown that without any goal or protocol for fluid resuscitation large inter- and intra-provider variability exist that have been correlated with poor patient outcomes Even under ideal study conditions strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation Hemodynamic monitors and protocols alone do not enable optimal fluid titration to be provided consistently to all patients - there must also be appropriate and timely interpretation and intervention
To address this problem of consistency and protocol adherence a decision support system Assisted Fluid Management AFM has been developed to help ease some of the work associated with GDFT protocol implementation The AFM system released on the European market in March 2017 may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers This artificial intelligence-based system can suggest administration of fluid boluses analyse the hemodynamic effects of the bolus and continually re-assess the patient for further fluid requirements
This system was recently implemented in a before-and-after study in a Belgian academic hospital where the authors reported that the implementation of this AFM software system allowed a better adherence to the GDFT algorithm However as this was a pilot study with a small number of patients the study was not powered to demonstrate a beneficial effect on the incidence of postoperative complications More recently a group from the Cleveland Clinic demonstrated that using AFM system resulted in more boluses being effective when compared to the administration of boluses without AFM support
There are no randomized controlled studies to date comparing this AFM system to standard of care on patient outcome We therefore aim to conduct a multicenter stepped-wedge cluster-randomized trial involving patients undergoing high risk abdominal surgery to compare a GDFT strategy guided by the AFM system with usual care
A stepped wedge cluster-randomized trial approach was chosen in which clusters will be randomized to commence the intervention at different times following an initial control period in which outcomes will be measured for usual care
So each center cluster began in the control phase and transitioned to the intervention phase at a randomly assigned time wedge The order in which each center will move from control to intervention phase will be randomly allocated by a computer algorithm performed by the study statistician
We selected cluster randomization rather than randomization of individual patients because the control group could be very different among centers from GDFT strategy using a flow monitoring to GDFT with a written protocol to no clear strategy use of an arterial line only without any advanced monitoring Interestingly this approach also decreases the Hawthorne effect which has been shown to decrease the incidence rate of the primary outcome in recent randomized trials because clinicians know that their patients are included in a research protocol
To address this problem of consistency and protocol adherence a decision support system Assisted Fluid Management AFM has been developed to help ease some of the work associated with GDFT protocol implementation The AFM system released on the European market in March 2017 may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers This artificial intelligence-based system can suggest administration of fluid boluses analyse the hemodynamic effects of the bolus and continually re-assess the patient for further fluid requirements
This system was recently implemented in a before-and-after study in a Belgian academic hospital where the authors reported that the implementation of this AFM software system allowed a better adherence to the GDFT algorithm However as this was a pilot study with a small number of patients the study was not powered to demonstrate a beneficial effect on the incidence of postoperative complications More recently a group from the Cleveland Clinic demonstrated that using AFM system resulted in more boluses being effective when compared to the administration of boluses without AFM support
There are no randomized controlled studies to date comparing this AFM system to standard of care on patient outcome We therefore aim to conduct a multicenter stepped-wedge cluster-randomized trial involving patients undergoing high risk abdominal surgery to compare a GDFT strategy guided by the AFM system with usual care
A stepped wedge cluster-randomized trial approach was chosen in which clusters will be randomized to commence the intervention at different times following an initial control period in which outcomes will be measured for usual care
So each center cluster began in the control phase and transitioned to the intervention phase at a randomly assigned time wedge The order in which each center will move from control to intervention phase will be randomly allocated by a computer algorithm performed by the study statistician
We selected cluster randomization rather than randomization of individual patients because the control group could be very different among centers from GDFT strategy using a flow monitoring to GDFT with a written protocol to no clear strategy use of an arterial line only without any advanced monitoring Interestingly this approach also decreases the Hawthorne effect which has been shown to decrease the incidence rate of the primary outcome in recent randomized trials because clinicians know that their patients are included in a research protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None