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Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation (SATIRE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181620
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Nicholas Sich, Abington Memorial Hospital

Brief Summary:

SATIRE is a prospective, randomized control trial assessing two methods of administration of intravenous sedation and narcotics in surgical patients requiring mechanical ventilation. Many hospitals use a continuous infusion method of administering these medications. The investigators hypothesize that intermittent, bolus/sliding-scale based administration will lead to less medication being given and subsequently decrease the amount of time on mechanical ventilation without compromising patient comfort or level of sedation.

Patients are randomized into a control arm (continuous infusion) and a trial arm (sliding scale hourly bolus) using versed for sedation and fentanyl for pain medication. Inclusion criteria are surgical patients requiring mechanical ventilation, including trauma patients, post operative patients, etc.

Primary end point is total time of mechanical ventilation in each arm. Secondary end points are amount of medication given, time in ICU, time to discharge. Mortality and adverse events in both arms are recorded and reported to the Institutional Review Board for monitoring.


Condition or disease Intervention/treatment Phase
Respiration, Artificial Postoperative Pain Postoperative Complications Other: Intermittent Dosing of Medication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Un-blinded, Prospective, Randomized Control Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation (SATIRE Trial): A Prospective, Randomized Cohort Study
Actual Study Start Date : September 8, 2016
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
No Intervention: Continuous Infusion Arm
Patients receive typical continuous infusions (drips) of both sedative agent and narcotic agent for sedation/pain control while mechanically ventilated based on RASS and CPOT.
Experimental: Intermittent Sliding Scale Arm
Patients receive hourly boluses of both sedative agent and narcotic agent for sedation/pain control while mechanically ventilated based on a sliding scale of RASS and CPOT.
Other: Intermittent Dosing of Medication
Typical sedative/narcotic medication administered for sedation while mechanically ventilated is given in an intravenous intermittent bolus fashion rather than a continuous intravenous drip.




Primary Outcome Measures :
  1. Total Time Mechanically Ventilated [ Time Frame: Two years ]
    Total time that the patient requires mechanical ventilation


Secondary Outcome Measures :
  1. ICU Length of Stay [ Time Frame: Two Years ]
    Total time in ICU

  2. Hospital Length of Stay [ Time Frame: Two Years ]
    Total time in Hospital

  3. Amount of Sedative Agent Given [ Time Frame: Two Years ]
    Total amount of sedative given in milligrams

  4. Amount of Narcotic Agent Given [ Time Frame: Two Years ]
    Total amount of narcotic agent given in micrograms

  5. Time at target level of sedation (RASS) in Both Arms [ Time Frame: Two Years ]
    Time at target level of sedation (RASS) in Both Arms

  6. Time at target level of pain control (CPOT) in Both Arms [ Time Frame: Two Years ]
    Time at target level of pain control (CPOT) in Both Arms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mechanical ventilation in the Surgical ICU.
  • Age >18 years old

Exclusion Criteria:

  • Use of dexmedetomidine (Precedex®)
  • Use of neuromuscular blocking agents
  • Use of propofol >24 hours
  • Discontinuation of midazolam as sedative (i.e., switching to propofol or dexmedetomidine)
  • Therapeutic hypothermia
  • Patients that do not require sedatives/narcotics while intubated (i.e. coma, traumatic brain injury)
  • Pregnancy
  • Prisoners
  • Patients with target RASS of -3 to -5 (Deep Sedation)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181620


Contacts
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Contact: Nicholas M Sich, M.D. 215-481-7170 nicholas.sich@jefferson.edu
Contact: Danielle Schulingkamp, RPh, BCPS 215-481-7120 danielle.schulingkamp@jefferson.edu

Locations
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United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Nicholas M Sich, M.D.    215-481-7170    nicholas.sich@jefferson.edu   
Contact: Danielle Schulingkamp, RPh, BCPS    215-481-7120    danielle.schulingkamp@jefferson.edu   
Principal Investigator: Nicholas M Sich, M.D.         
Sub-Investigator: Danielle Schulingkamp, RPh, BCPS         
Sub-Investigator: Danelle Bertozzi, M.D.         
Sub-Investigator: Olivier VanHoutte, M.D.         
Sub-Investigator: Ryan Shadis, M.D.         
Sponsors and Collaborators
Abington Memorial Hospital
Publications:

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Responsible Party: Nicholas Sich, Resident Physician, Abington Memorial Hospital
ClinicalTrials.gov Identifier: NCT03181620    
Other Study ID Numbers: AbingtonMH
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes