Recruiting

Sedation

Sponsor:

Abington Memorial Hospital

Code:

NCT03181620

Conditions

Respiration, Artificial

Postoperative Pain

Postoperative Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intermittent Dosing of Medication

Study Details

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.

Conditions

Respiration, Artificial

Postoperative Pain

Postoperative Complications

Study ID

NCT03181620

Start date

Sep 8, 2016

Status verified date

Jan, 2019

Completion date

Apr, 2019

Anticipated

Primary completion date

Mar 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Total Time Mechanically Ventilated [ Time Frame: Two years ]

Central Contacts and Locations

Central contacts

Locations

Abington Memorial Hospital

Recruiting

Abington, Pennsylvania, United States, 19001

Contacts

Principal Investigator:

Nicholas M Sich, M.D.

More Information

Sponsor

Abington Memorial Hospital

Last update posted

Jan 9, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abington Memorial Hospital on 2019-01-09.