Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The PATHFINDER Study: A Feasibility Trial (PATHFINDER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016740
Recruitment Status : Completed
First Posted : July 11, 2019
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE August 20, 2019
Actual Primary Completion Date February 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
Incidence of Delirium [ Time Frame: Participants will be followed for the duration of the hospital stay, an average of 5 days ]
Incidence of delirium will be analyzed in patients treated with the multi-modal approach. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM)Assessment Method (CAM) algorithm postoperatively until discharge.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • Time to extubation [ Time Frame: Time of ICU admission until time of extubation in ICU, an average of 6 hours ]
    Time to extubation will be noted from ICU data
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: On the day of discharge, an average of 6 days ]
    MoCA scores (total possible score is 30 points; a score of 26 or above is considered normal) at discharge will be reported in order to assess the occurrence of postoperative cognitive decline. Study staff trained in administering the assessments will collect the data.
  • Pain scores [ Time Frame: At 4-8 hourly intervals every day until discharge, an average of 6 days ]
    Patient reported pain scores on a scale from 0-10 (0 no pain,10 extreme pain), until discharge for the index admission.
  • Total opioid and supplemental analgesic consumption [ Time Frame: 48 hours, post-operative ]
    The total opioid dosage and supplemental analgesic dosage received in the first 48 hours postoperatively will be abstracted from the medical record.
  • ICU [ Time Frame: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days ]
    Total duration of stay in ICU for the index admission
  • ICU/hospital length of stay [ Time Frame: Time of stay in the hospital until discharge to floor or rehab, an average of 5 days ]
    Their stay in the hospital for the index admission
  • In-hospital complications [ Time Frame: 7 days post-op on an average ]
    stroke, myocardial infarction (MI), acute kidney injury, pneumonia, reintubation, congestive heart failure, sepsis, reopening of sternum and all-cause mortality
  • Follow up incidence of delirium [ Time Frame: Patients will be assessed for delirium at 1 month and 6 months following the date of surgery ]
    The follow up incidence of delirium will be analyzed at 1 month and 6 months after discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the MoCA/t-MoCA.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PATHFINDER Study: A Feasibility Trial
Official Title  ICMJE Perioperative Multimodal General Anesthesia Focusing on Specific CNS Targets in Patients Undergoing Cardiac Surgeries
Brief Summary The main purpose of this study is to determine whether a rational strategy of EEG guided multimodal general anesthesia using target specific sedative and analgesics could result in enhanced recovery after anesthesia and surgery, decrease in postoperative delirium, and decrease in long term postoperative cognitive dysfunction up to 6 months following cardiac surgery.
Detailed Description

The main purpose of this study is to determine whether a rational strategy of EEG guided multimodal general anesthesia using target specific sedative and analgesics could result in enhanced recovery after anesthesia and surgery, decrease in postoperative delirium, and decrease in long term postoperative cognitive dysfunction up to 6 months following cardiac surgery.

Specific Aim 1: The feasibility of implementing multimodal general anesthesia strategy in the Operating Rooms (OR) Specific Aim 2: The feasibility of implementing EEG guided sedation until extubation in the Intensive Care Unit (ICU) Specific Aim 3: The enhancement of recovery after surgery (shorter ventilation time, ICU stay, hospital length of stay) Specific Aim 4: To estimate the effect size of decrease in postoperative day (POD) and postoperative cognitive dysfunction (POCD) to power future large randomized trials

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
2 roll-in patients followed by 20 patients in the interventional model.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Coronary Artery Disease
  • Delirium
Intervention  ICMJE
  • Drug: Ropivacaine
    Intraoperative bilateral PIFB block with 20 mL of 0.25% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision
  • Drug: Ketamine
    Intraoperative infusion
  • Drug: Remifentanil
    Intraoperative infusion
  • Drug: Dexmedetomidine
    Intraoperative infusion
  • Drug: Rocuronium
    Intraoperative intermittent bolus
  • Drug: Propofol
    Intraoperative infusion
  • Drug: Sevoflurane
    Intraoperative inhaled as needed
  • Drug: Dexmedetomidine
    Post-operative infusion
  • Drug: Propofol
    Post-operative infusion
  • Device: EEG monitoring
    Perioperative monitoring
Study Arms  ICMJE
  • Experimental: Multimodal General Anesthesia

    Intraoperative

    The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. They will also be trained in titrating hypnotic and nociceptic medications based on changes in EEG.

    1. Routine anesthetic induction
    2. Bilateral Pectoro-interfascial block (PIFB) with 20 mL of 0.25% ropivacaine on either side of the sternum after anesthetic induction but before surgical incision
    3. Ketamine (0.06 to 0.12 mg.kg/hr)
    4. Remifentanil (0.05-0.2 mcg/kg/min)
    5. Dexmedetomidine (0.2-1.0 mcg/kg/hr)
    6. Rocuronium intermittent bolus (TOF)
    7. Propofol infusion ± Sevoflurane titrated based on EEG monitoring

    Postoperative

    1. Standard pain management protocol
    2. Dexmedetomidine infusion 0.2-1.4 mcg/kg/hr (EEG guided)
    3. Infusion continued till extubation
    4. Propofol infusion may be added/used for sedation based on the treating physician's discretion
    Interventions:
    • Drug: Ropivacaine
    • Drug: Ketamine
    • Drug: Remifentanil
    • Drug: Dexmedetomidine
    • Drug: Rocuronium
    • Drug: Propofol
    • Drug: Sevoflurane
    • Drug: Dexmedetomidine
    • Drug: Propofol
    • Device: EEG monitoring
  • Standard Practice with EEG monitoring
    The initial 2 patients will receive standard anesthesia practice and perioperative EEG monitoring will be recorded to learn the patterns associated with our standard practice.
    Intervention: Device: EEG monitoring
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2019)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 7, 2020
Actual Primary Completion Date February 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 60 years
  2. Undergoing any of the following types of surgery with cardiopulmonary bypass limited to coronary artery bypass surgery (CABG), CABG+valve surgeries and isolated valve surgeries.

Exclusion Criteria:

  1. Preoperative left ventricular ejection fraction (LVEF) <30%
  2. Emergent surgery
  3. Non-English speaking
  4. Cognitive impairment as defined by total MoCA score < 10
  5. Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
  6. Significant visual impairment
  7. Chronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
  8. Hypersensitivity to any of the study medications
  9. Known history of alcohol (> 2 drinks per day) or drug abuse Active (in the past year) history of alcohol abuse (≥5 drinks/day for men or ≥4 drinks/day for women) as determined by reviewing medical record and history given by the patient
  10. Liver dysfunction (liver enzymes > 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04016740
Other Study ID Numbers  ICMJE 2019P000407
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Balachundhar Subramaniam, MD, MPH Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP