Analgesia-First Sedation for Respiratory Failure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MemorialCare Health System

Must be taking: Sedatives, Analgesics

Must not be taking: Neuromuscular blockers

Disqualifiers: Cardiac arrest, Neurological deficit, Alcohol dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

170 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{2 3 5 6 7}

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Analgesia First Sedation Experimental Treatment 1 Intervention

Subjects will be randomized to receive analgesia-first sedation by intermittent doses of Fentanyl (25 mcg), instead of continuous IV infusions. If the intermittent IVP x4 fails to achieve the target pain score, an infusion starts at 50 mcg/hr and titration by 25 mcg q15 minutes. If sedation score is not achieved, propofol infusion starts at 5 mcg/kg/min to achieve goal RASS of 0 to -2. Subjects will be assessed for a ventilator weaning trial daily.

Group II: Protocol Directed Sedation and Daily Sedation Interruption Active Control 1 Intervention

Subjects will receive Fentanyl for analgesia and midazolam for sedation management. The RASS score is used to guide sedation to a goal of 0 to -2 and daily sedation by IV Midazolam at 1 mg/hr and titrated by 1 mg/hr q60 mins. Midazolam boluses are allowed by 1 mg IVP q5 mins x2 before increasing the infusion rate. Propofol and dexmedetomidine are permitted under existing institutional sedation protocol. Fentanyl IV starts at 50 mcg/hr and is titrated by 25 mcg/hr q15 mins to achieve target pain score. Fentanyl bolus of 25 mcg IVP q5 min x2 doses is given before increasing the infusion rate. Daily sedation interruption (DSI) is performed daily and ventilator weaning trial if they pass.

Who Is Running the Clinical Trial?

MemorialCare Health System

Lead Sponsor

Trials

21

Recruited

2,600+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A sedation strategy that focuses on minimizing changes in consciousness while ensuring comfort and adaptation to mechanical ventilation is feasible for critically ill patients, even though high doses of sedatives may be needed for those with severe conditions like ARDS or ICH.

Using a structured sedation algorithm can significantly reduce the duration of mechanical ventilation by up to 50%, highlighting the importance of a multidisciplinary approach in managing sedation effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of the sedated patient]. De Jonghe, B., Appéré-De-Vecchi, C., Outin, H.[2020]

Standardized pain assessment using tools like the Behavioral Pain Scale (BPS) and Critical-Care Pain Observation Tool (CPOT) is crucial for providing effective pain management in mechanically ventilated patients, yet assessment rates in ICUs remain low.

Implementing an analgesia-first sedation approach and maintaining patients in lighter sedation states can lead to better clinical outcomes, highlighting the importance of individualized and patient-centered care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress of pain assessment and analgesia strategy for mechanical ventilation patients]. Li, Q., Wan, X.[2019]

The implementation of an analgesia/sedation protocol (ASP) in a surgical ICU significantly reduced the use of fentanyl and midazolam, leading to a decrease in cumulative dosages of these medications (P < 0.001 for fentanyl and P = 0.001 for midazolam).

Patients managed under the ASP achieved sedation goals more effectively (86.8% vs. 74.4%, P < 0.001) and experienced fewer days on mechanical ventilation (3.8 days vs. 5.9 days, P = 0.033), indicating improved management of sedation and pain in critically ill surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre- and post-intervention study to assess the impact of a sedation protocol in critically ill surgical patients. Porhomayon, J., Nader, ND., El-Solh, AA., et al.[2015]

In a study of 105 critically ill patients, remifentanil-based sedation significantly reduced the duration of mechanical ventilation by over 2 days and improved the weaning process, leading to faster extubation compared to conventional midazolam-based sedation.

Remifentanil was well tolerated and allowed for a lower total dose of midazolam, with no evidence of drug accumulation or tolerance, indicating its safety and efficacy for prolonged sedation in ICU patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]. Breen, D., Karabinis, A., Malbrain, M., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Current sedation practices: lessons learned from international surveys. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An analgesia-delirium-sedation protocol for critically ill trauma patients reduces ventilator days and hospital length of stay. [2022]

3. Argentina pubmed.ncbi.nlm.nih.gov

Impact of the implementation of a sedation and analgesia protocol in a pediatric intensive care unit. [2023]

4. France pubmed.ncbi.nlm.nih.gov

[Management of the sedated patient]. [2020]

5. China pubmed.ncbi.nlm.nih.gov

[Progress of pain assessment and analgesia strategy for mechanical ventilation patients]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Pre- and post-intervention study to assess the impact of a sedation protocol in critically ill surgical patients. [2015]

7. England pubmed.ncbi.nlm.nih.gov

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]