Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation (SATIRE)
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|ClinicalTrials.gov Identifier: NCT03181620|
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : January 9, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Un-blinded, Prospective, Randomized Control Trial|
|Masking:||None (Open Label)|
|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|
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.
- Total Time Mechanically Ventilated [ Time Frame: Two years ]Total time that the patient requires mechanical ventilation
- ICU Length of Stay [ Time Frame: Two Years ]Total time in ICU
- Hospital Length of Stay [ Time Frame: Two Years ]Total time in Hospital
- Amount of Sedative Agent Given [ Time Frame: Two Years ]Total amount of sedative given in milligrams
- Amount of Narcotic Agent Given [ Time Frame: Two Years ]Total amount of narcotic agent given in micrograms
- Time at target level of sedation (RASS) in Both Arms [ Time Frame: Two Years ]Time at target level of sedation (RASS) in Both Arms
- 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
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
|Contact: Nicholas M Sich, M.D.||firstname.lastname@example.org|
|Contact: Danielle Schulingkamp, RPh, BCPSemail@example.com|
|United States, Pennsylvania|
|Abington Memorial Hospital||Recruiting|
|Abington, Pennsylvania, United States, 19001|
|Contact: Nicholas M Sich, M.D. 215-481-7170 firstname.lastname@example.org|
|Contact: Danielle Schulingkamp, RPh, BCPS 215-481-7120 email@example.com|
|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.|