Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study on Pairing Sedation Strategies and Weaning

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: NCT02219659
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Memorial Medical Center Foundation
Information provided by (Responsible Party):
MemorialCare Health System

Tracking Information
First Submitted Date  ICMJE February 20, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE April 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Determining the feasibility of conducting the study protocol [ Time Frame: Up to 180 days ]
    This is the rate on enrollment and number of protocol non-adherence
  • Mechanical ventilation free days [ Time Frame: Up to 180 days ]
    This is the number of days where patients were breathing without assistance during the study period.
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Mechanical ventilation free days [ Time Frame: Up to 180 days ]
This is the number of days where patients were breathing without assistance during the study period.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
  • Duration of weaning [ Time Frame: Up to 180 days ]
    Time from initiation of weaning until successful extubation
  • ICU length of stay [ Time Frame: Up to 180 days ]
    The number of days from ICU admission to ICU discharge
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 Pilot Study on Pairing Sedation Strategies and Weaning
Official Title  ICMJE Comparing Strategies of Pairing Sedation and Weaning Protocols on Outcomes of Mechanical Ventilation: A Pilot Study
Brief Summary A three-arm, randomized, pilot feasibility, study to assess the effect three validated sedation strategies on outcomes of patient on mechanical ventilation.
Detailed Description

A three-arm, randomized, pilot feasibility, study to assess the effect three validated sedation strategies on outcomes of patient on mechanical ventilation.

A significant proportion of patients admitted to the intensive care unit (ICU) require mechanical ventilation (MV). To maintain comfort and facilitate quality care, large quantities of sedatives and analgesics are often administered either by continuous infusion, with or without daily interruption (DI) of sedation, or as intermittent doses of analgesics. Three validated sedation strategies are currently available. A recently published study ( trial has shown that instituting protocol-directed sedation in patients requiring continuous infusion of sedatives and analgesics, whether or not daily interruption (DI) of the sedative occurs, will improve MV outcomes, specifically the duration of MV. Girard et al performed a randomized, multicenter, clinical trial (ABC- Awakening and Breathing Controlled trial) evaluating the pairing of a spontaneous awakening trial (SAT) with an SBT. Most recently, a Danish study by Strom et al. investigated whether an analgesia-first approach to patient comfort that consisted of intermittent doses of intravenous opioids, and the initiation of IV sedation for short periods only when acute agitation was present, would be superior to a protocol similar to the ABC trial. While the three above mentioned approaches are accepted and currently implemented in the critical care community there is no comparative study or evaluation on the optimal timing to conduct a spontaneous breathing trial (SBT) for assessing weaning readiness with each of these strategies. It is possible that a SAT strategy, where sedative and opioid infusions are interrupted, may lead to more agitation and anxiety than a strategy in patients managed with a sedation protocol where intravenous sedative and analgesic therapy is regularly titrated to maintain patients in a lightly sedated state. Moreover, it remains unclear whether there are advantages of an analgesia-first sedation strategy over either an SAT or sedation protocol strategy in terms of the time it takes to wean patients from MV. However, it is noteworthy to mention that the analgesia-first strategy was associated with more delirium episodes, which were attributed to the ability to assess for it in a more awake patient. However, comparing delirium occurrence in studies with different sedation goals and methodologies may be inaccurate.

The investigators therefore propose a three-arm, randomized, pilot feasibility, study to assess the effect of these three (3) validated strategies for sedation and pain management

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Respiratory Failure
Intervention  ICMJE
  • Drug: Sedation Protocol with Daily Interruption
    Continuous infusion of fentanyl and midazolam is started and titrated to target pain and RASS score: Fentanyl started at 25 mcg/hr titrated by 25 mcg/hr every 30 minutes to goal pain score; Midazolam started at 1 mg/hr titrated by 1 mg/hr every hour to goal RASS score for the study design duration (28 days) or for the duration of mechanical ventilation. Every morning both infusions are stopped and when the patient is awake and met the SBT safety screen, 120-min CPAP trial is performed. If the patient meets the CPAP passing criteria, arterial blood gas (ABG) is done and the patient is placed back to the previous ventilator setting. ABG result is notified to the physician for determination for extubation. If the patient does not pass the CPAP trial it is repeated next morning.
    Other Names:
    • fentanyl
    • midazolam
  • Drug: Sedation Protocol Without Daily Interruption
    Continuous infusion of fentanyl and midazolam is started and titrated to target pain and RASS score: Fentanyl started at 25 mcg/hr titrated by 25 mcg/hr every 30 minutes to goal pain score; Midazolam started at 1 mg/hr titrated by 1 mg/hr every hour to goal RASS score for the study design duration (28 days) or for the duration of mechanical ventilation. Every morning when the patient's RASS score is 0 to -2 and the patient passes the SBT safety screen, 120-min CPAP trial is performed. If the patient meets the CPAP passing criteria, arterial blood gas (ABG) is done and the patient is placed back to the previous ventilator setting. ABG result is notified to the physician for determination for extubation. If the patient does not pass the CPAP trial it is repeated next morning.
    Other Names:
    • fentanyl
    • midazolam
  • Drug: Fentanyl Push First
    Fentanyl 25 mcg intravenous push (IVP) every 5 min up to 4 doses hourly as needed to target pain score for the study design duration (28 days) or for the duration of mechanical ventilation. Every morning when patient's RASS is 0 to -2 and passes the SBT safety screen, 120-min CPAP trial is performed. If patient meets CPAP passing criteria, the physician will be notified for determination of extubation. If patient does not pass, it is repeated next morning. If target RASS is not achieved with fentanyl IV push alone, study team is notified and fentanyl infusion at 50 mcg/hr titrated by 25 mcg/hr every 30 min to target pain score (max 6 hrs). If target RASS score is not achieved with the fentanyl IV, propofol infusion is started at 5 mcg/kg/hr titrated by 5 mcg/kg/hr every 15 min to target RASS score (max 6 hrs).
    Other Names:
    • fentanyl
    • propofol
Study Arms  ICMJE
  • Active Comparator: Sedation protocol with interruption
    Continuous infusion of fentanyl and midazolam is started per protocol. Both drugs are titrated to target pain score (0 to 3) using Critical Care Pain Observation Tool (CPOT) and target sedation score (0 to -3) using Richmond Agitation Sedation Scale (RASS). Every morning both drugs are stopped (Daily Interruption) and patient's wakefulness is assessed per protocol. If patient's pain and RASS score stays within the target, both drugs are kept off. If patient shows any signs and symptoms of pain or agitation (described in the study protocol), both drugs are restarted at a half dose of the previous dose and titrated to target pain and RASS score. Every morning both drugs are stopped and when patient is awake and met the SBT safety screen, 120-min continuous positive airway pressure (CPAP) trial is performed.
    Intervention: Drug: Sedation Protocol with Daily Interruption
  • Active Comparator: Sedation protocol without Interruption
    Continuous infusion of fentanyl and midazolam is started per protocol. Both drugs are titrated to target pain score (0 to 3) using Critical Care Pain Observation Tool (CPOT) and target sedation score (0 to -3) using Richmond Agitation Sedation Scale (RASS). Daily interruption of fentanyl and midazolam is not performed. Every morning 120-min CPAP trial is performed as long as the patient's RASS score is 0 to -2 and the patient passes the SBT safety screen.
    Intervention: Drug: Sedation Protocol Without Daily Interruption
  • Active Comparator: Fentanyl push first
    This arm attempts to manage patient's pain and agitation with analgesia first. Fentanyl intravenous (IV) pushes are administered every 5 minutes as needed to target pain and sedation score, up to 4 doses per hour. Every morning 120-min CPAP trial is performed as long as patient's RASS score is 0 to -2 and patient passes the SBT safety screen. If fentanyl IV push doses alone cannot manage patient's pain and agitation (could not reach the target score), notify the study team. Fentanyl infusion is started and titrated to target pain and sedation score up to 6 hours. If fentanyl infusion is titrated up twice consecutively and target pain and sedation score are not met, notify the study team. Propofol infusion is started and titrated to target RASS score up to 6 hours.
    Intervention: Drug: Fentanyl Push First
Publications * Not Provided

*   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: August 15, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥ 18 years of age
  2. Mechanically ventilated with an expected duration of MV ≥ 48 hours
  3. ICU team has initiated continuous sedative and/or /analgesic infusions

Exclusion criteria:

  1. Admission after resuscitation from cardiac arrest
  2. Admission with traumatic brain injury or another acute neurologic event (e,g. stroke, uncontrolled seizures).
  3. History of severe dementia
  4. Admission because of acute alcohol withdrawal or acute drug intoxication
  5. Administration of more than 24 hours of continuous sedation
  6. Allergy to fentanyl, midazolam, and/or propofol
  7. Lack of informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT02219659
Other Study ID Numbers  ICMJE 25613
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party MemorialCare Health System
Study Sponsor  ICMJE MemorialCare Health System
Collaborators  ICMJE Memorial Medical Center Foundation
Investigators  ICMJE
Principal Investigator: Maged Tanios, MD, MPH Long Beach Memorial Medical Center
PRS Account MemorialCare Health System
Verification Date March 2019

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