170 Participants Needed

Analgesia-First Sedation for Respiratory Failure

MT
HP
Overseen ByHyunsoon Park, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: MemorialCare Health System
Must be taking: Sedatives, Analgesics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The study's aim is to ascertain the best approach for providing sedation and pain management for patients who have sustained trauma and are requiring respiratory support from a mechanical ventilator. The common approach to patients who need mechanical ventilation is to provide continuous drips of sedatives and pain medicine and awaken the patient once a day to check the brain functions. Another approach is to provide pain medicine and reserve sedatives for only a short duration when needed. The difference between approaches has not been studied in Trauma patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving neuromuscular blocking agents or have allergies to certain sedatives, you may not be eligible to participate.

Is analgesia-first sedation safe for humans?

Research shows that using an analgesia-first sedation strategy, which prioritizes pain relief before sedation, can be safe and may reduce the need for continuous drug infusions in critically ill patients. This approach has been associated with improved outcomes, such as shorter mechanical ventilation duration and hospital stays, when implemented with proper protocols and monitoring.12345

How is the Analgesia-First Sedation Strategy for mechanically ventilated trauma patients different from other treatments?

The Analgesia-First Sedation Strategy prioritizes pain relief before sedation, aiming to keep patients comfortable and awake, which can reduce the time on mechanical ventilation and hospital stay compared to traditional continuous sedative infusions.12567

What data supports the effectiveness of the Analgesia First Sedation Strategy for Mechanically Ventilated Trauma Subjects treatment?

Research shows that using an analgesia-first sedation strategy, which prioritizes pain relief before sedation, can reduce the duration of mechanical ventilation and hospital stays. Implementing sedation protocols and daily sedation interruption has been associated with improved patient outcomes, such as reduced drug use and better management of sedation levels.12345

Who Is on the Research Team?

MT

Maged Tanios, MD, MPH

Principal Investigator

Long Beach Memorial Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are on mechanical ventilation due to trauma, expected to need it for at least 48 hours, and can potentially be weaned off. It's not suitable for those with chronic neurological issues, allergies to certain sedatives, a history of substance abuse, prior continuous sedation from another hospital or those on muscle relaxants.

Inclusion Criteria

You are currently using a breathing machine and are expected to continue using it for at least 48 hours.
I am considered for weaning off mechanical ventilation.
I am receiving continuous pain or sedation medication from the ICU team.

Exclusion Criteria

I have a long-term neurological condition that affects my daily activities.
You are allergic to midazolam, lorazepam, or propofol.
I was admitted to the hospital after being revived from a cardiac arrest.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either protocol-directed sedation with daily sedation interruption or analgesia-first sedation while on mechanical ventilation

28 days
Daily assessments in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events related to mechanical ventilation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Analgesia First Sedation Strategy for Mechanically Ventilated (MV) Trauma Subjects
  • Protocol Directed Sedation and Daily Sedation Interruption
Trial Overview The study compares two methods of managing pain and sedation in mechanically ventilated trauma patients: the usual method with daily wake-up checks versus an 'analgesia-first' strategy that prioritizes pain management and minimizes sedative use.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Analgesia First SedationExperimental Treatment1 Intervention
Group II: Protocol Directed Sedation and Daily Sedation InterruptionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MemorialCare Health System

Lead Sponsor

Trials
21
Recruited
2,600+

Published Research Related to This Trial

Individualized sedation management, which includes using assessment tools and protocols, can significantly improve patient outcomes in mechanically ventilated adults in the ICU.
Despite the availability of effective strategies and guidelines for sedation and analgesia, their implementation in clinical practice remains slow, highlighting the need for better education and research in this area.
Current sedation practices: lessons learned from international surveys.Mehta, S., McCullagh, I., Burry, L.[2022]
The implementation of an Analgesia-Delirium-Sedation (ADS) protocol in critically ill trauma patients significantly reduced the median duration of mechanical ventilation from 3.2 days to 1.2 days, indicating improved respiratory outcomes.
Patients under the ADS protocol also experienced a shorter hospital stay, averaging 12 days compared to 18 days in the control group, while also requiring less sedative medication, demonstrating both efficacy and potential safety benefits.
An analgesia-delirium-sedation protocol for critically ill trauma patients reduces ventilator days and hospital length of stay.Robinson, BR., Mueller, EW., Henson, K., et al.[2022]
The implementation of a sedation and analgesia protocol in a pediatric intensive care unit led to a significant reduction in the continuous infusion of opioids and benzodiazepines in patients requiring mechanical ventilation for more than 72 hours, with opioid use decreasing from 7.6 to 6 days and benzodiazepine use from 7.6 to 3.3 days.
This study involved 191 patients (99 pre-intervention and 92 post-intervention) and highlights the effectiveness of structured protocols in managing sedation and analgesia, although no significant changes were observed in overall mechanical ventilation days.
Impact of the implementation of a sedation and analgesia protocol in a pediatric intensive care unit.Taffarel, P., Widmer, J., Fiore, Á., et al.[2023]

Citations

Current sedation practices: lessons learned from international surveys. [2022]
An analgesia-delirium-sedation protocol for critically ill trauma patients reduces ventilator days and hospital length of stay. [2022]
Impact of the implementation of a sedation and analgesia protocol in a pediatric intensive care unit. [2023]
[Management of the sedated patient]. [2020]
[Progress of pain assessment and analgesia strategy for mechanical ventilation patients]. [2019]
Pre- and post-intervention study to assess the impact of a sedation protocol in critically ill surgical patients. [2015]
Decreased duration of mechanical ventilation when comparing analgesia-based sedation using remifentanil with standard hypnotic-based sedation for up to 10 days in intensive care unit patients: a randomised trial [ISRCTN47583497]. [2018]
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