Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation

NCT03181620 | Unknown DMC

• 1 other identifier: AbingtonMH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total Time Mechanically Ventilated

  Total time that the patient requires mechanical ventilation

  Two years

Secondary Outcomes (6)

• ICU Length of Stay

  Two Years

• Hospital Length of Stay

  Two Years

• Amount of Sedative Agent Given

  Two Years

• Amount of Narcotic Agent Given

  Two Years

• Time at target level of sedation (RASS) in Both Arms

  Two Years

Study Arms (2)

Continuous Infusion Arm

NO INTERVENTION

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.

Intermittent Sliding Scale Arm

EXPERIMENTAL

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

Interventions

Intermittent Dosing of Medication OTHER

Typical sedative/narcotic medication administered for sedation while mechanically ventilated is given in an intravenous intermittent bolus fashion rather than a continuous intravenous drip.

Intermittent Sliding Scale Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abington Memorial Hospital: lead

Study Sites (1)

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

RECRUITING

Related Publications (7)

• Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.

  PMID: 10816184 BACKGROUND

• Kress JP, Pohlman AS, Hall JB. Sedation and analgesia in the intensive care unit. Am J Respir Crit Care Med. 2002 Oct 15;166(8):1024-8. doi: 10.1164/rccm.200204-270CC. No abstract available.

  PMID: 12379543 BACKGROUND

• Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.

  PMID: 11902253 BACKGROUND

• Cernaianu AC, DelRossi AJ, Flum DR, Vassilidze TV, Ross SE, Cilley JH, Grosso MA, Boysen PG. Lorazepam and midazolam in the intensive care unit: a randomized, prospective, multicenter study of hemodynamics, oxygen transport, efficacy, and cost. Crit Care Med. 1996 Feb;24(2):222-8. doi: 10.1097/00003246-199602000-00007.

  PMID: 8605792 BACKGROUND

• Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.

  PMID: 9726743 BACKGROUND

• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

  PMID: 12421743 BACKGROUND

• Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7.

  PMID: 16823021 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration; Pain, Postoperative; Postoperative Complications

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Nicholas M Sich, M.D.

CONTACT

215-481-7170; nicholas.sich@jefferson.edu

Danielle Schulingkamp, RPh, BCPS

CONTACT

215-481-7120; danielle.schulingkamp@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: Un-blinded, Prospective, Randomized Control Trial

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: September 8, 2016
• Primary Completion: March 31, 2019
• Study Completion: April 1, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)