Pilot Study on Pairing Sedation Strategies and Weaning

NCT02219659 | Completed Results DMC

• 1 other identifier: 25613
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A three-arm, randomized, pilot study, to assess the feasibility for the analgesia-first sedation (AFS) study arm/intervention (Fentanyl push first). The study will assess additional outcomes for all three (3) validated strategies for sedation and pain management.

Conditions

Acute Respiratory Failure

Keywords

sedation strategy; mechanical ventilation; ventilator weaning

Outcome Measures

Primary Outcomes (1)

• Study Feasibility

  Study feasibility for all 3 Arms/Groups (i.e., "Fentanyl Push First", "Sedation Protocol Without Interruption", and "Sedation Protocol with Interruption") being greater than or equal to 80% and protocol feasibility was based on protocol compliance (total percentage of study days participants were compliant with protocol).

  Up to 28 days

Secondary Outcomes (1)

• ICU Length of Stay

  Up to 28 days

Other Outcomes (2)

• Mechanical Ventilation Free Days

  Up to 28 days

• Duration of Weaning

  Up to 28 days

Study Arms (3)

Sedation protocol with interruption

ACTIVE COMPARATOR

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.

Drug: Sedation Protocol with Daily Interruption

Sedation protocol without Interruption

ACTIVE COMPARATOR

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.

Drug: Sedation Protocol Without Daily Interruption

Fentanyl push first

ACTIVE COMPARATOR

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.

Drug: Fentanyl Push First

Interventions

Sedation Protocol with Daily Interruption DRUG

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.

Also known as: fentanyl, midazolam

Sedation protocol with interruption

Sedation Protocol Without Daily Interruption DRUG

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.

Also known as: fentanyl, midazolam

Sedation protocol without Interruption

Fentanyl Push First DRUG

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).

Also known as: fentanyl, propofol

Fentanyl push first

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Admission after resuscitation from cardiac arrest
• Admission with traumatic brain injury or another acute neurologic event (e,g. stroke, uncontrolled seizures).
• History of severe dementia
• Admission because of acute alcohol withdrawal or acute drug intoxication
• Administration of more than 24 hours of continuous sedation
• Allergy to fentanyl, midazolam, and/or propofol
• Lack of informed consent

Sponsors & Collaborators

• MemorialCare Health System: lead
• Memorial Medical Center Foundation: collaborator

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

MeSH Terms

Interventions

Fentanyl; Midazolam; Propofol

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Division of Pulmonary and Critical Care
• Organization: MemorialCare Long Beach

mtanios@yahoo.com

(562) 933-2000

Study Officials

• Maged Tanios, MD, MPH

  Long Beach Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: August 19, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 18, 2018
• Last Updated: October 7, 2025
• Results First Posted: May 14, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)