Mechanical VentilationNCT04263662
Implementation of an Analgesia-sedation Algorithm in the Pediatric ICU to Reduce Benzodiazepine Use
An observational study of Mechanical Ventilation and Sedation, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of the study is to develop and implement an evidence-based analgesia-sedation algorithm in the pediatric intensive care unit (PICU) using quality improvement and implementation science methodology. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Mechanical Ventilation, Sedation
- What is being tested?
- Analgesia-Sedation algorithm
- How many people
- 680 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients admitted to the ICU who receive invasive mechanical ventilation via an endotracheal or nasotracheal tube and are potentially eligible to follow the analgesia-sedation algorithm.
Who may be able to join
- Admitted to the pediatric ICU between August 1st 2017 - February 28th 2018 and August 1st 2019 - February 28th 2020
- Intubated for greater than 24 hours will be eligible
Who cannot join
- Ventilated via a tracheostomy at the time of admission
- Pre-admission documentation of dexmedetomidine allergy
- Receiving a midazolam infusion for greater than 4 hours at the time of admission
- Admitted to the ICU for initiation of the rapid-escalation midazolam protocol for status epilepticus
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Implementation of a New Analgesia-sedation Algorithm in the Pediatric Intensive Care Unit to Reduce Overall Benzodiazepine Usage
The purpose of the study is to develop and implement an evidence-based analgesia-sedation algorithm in the pediatric intensive care unit (PICU) using quality improvement and implementation science methodology. The analgesia-sedation protocol will be implemented for patients admitted to the pediatric ICU who require mechanical ventilation for greater than 24 hours. Specifically, we will examine the impact of this implementation on total benzodiazepine usage, ICU length of stay, and ventilator free days, using a pre- and post- algorithm implementation comparative design.
Read the detailed description
Study Design and exposures:
- Development of an evidence-based analgesia-sedation algorithm for mechanically ventilated children using an iterative, multidisciplinary collaborative effort.
- Exposure: Implementation of the analgesia-sedation algorithm using standard quality improvement (QI) methodology. This will include education, awareness, wash-in phases followed by actual implementation with support. We will use a before-after comparison design.
Patients will be eligible if they are admitted to the medical and multidisciplinary (medical/surgical) ICUs at Boston Children's Hospital and require mechanical ventilatory support for greater than 24 hours.
Study period: Eligible patients who are admitted to the ICUs between August 1st 2017 - February 28th 2018 (pre-implementation) and August 1st 2019 - February 28th 2020 (post-implementation) will be enrolled.
Data collection: Retrospective chart review, with manual data entry in REDCap. Pre-intervention data will be collected starting July 2019. After the intervention begins in July 2019, data collection will occur monthly with the intent of collecting compliance data through analyzing usage of a new electronic medical record order set designed specifically for this intervention and feeding that back to staff members via electronic communication and meeting presentations in order to assess barriers to implementation of the new algorithm. Prospective post-intervention data collection will begin in September 2019 and end in March 2020.
- Conditions
- Mechanical Ventilation, Sedation
- Being tested
- Analgesia-Sedation algorithm
- Keywords
- Analgesia, Sedation, Dexmedetomidine, Mechanical Ventilation, Delirium
- Medical subject headings
- Agnosia, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia-Sedation algorithmOther
The analgesia-sedation algorithm is a suggested protocol for approach to providing analgesia and sedation to patients admitted to the pediatric ICU who are newly intubated. The approach focuses on using dexmedetomidine as the primary sedative, non-opioids as the primary analgesia, then stepwise approach to adding in adjunctives (e.g. opioids, non-benzodiazepines) with the intention of minimizing benzodiazepine exposure and utilizing minimal-dose effective analgesia/sedative dosing.
| Study group | Role | What they receive |
|---|---|---|
| Pre-algorithm | Patients admitted to the pediatric ICU who are intubated for greater than 24 hours prior to implementation of an analgesia-sedation algorithm. | |
| Post-algorithm | Patients admitted to the pediatric ICU who are intubated for greater than 24 hours after implementation of an analgesia-sedation algorithm. Receives: Other: Analgesia-Sedation algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benzodiazepine exposure
Total exposure of benzodiazepines (midazolam, lorazepam, diazepam) measured per kilogram of weight over the patient's duration of ICU stay.
Measured: We will collect data (after hospital discharge) on amount of benzodiazepine administration in their ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Secondary outcomes (6)
Opioid exposure
Total exposure of opioids (measured in morphine equivalents) measured per kilogram of weight over the patient's duration of ICU stay.
Measured: We will collect data (after hospital discharge) on amount of opioid administration in their ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
ICU length of stay
Duration of stay in the ICU measured in days
Measured: We will collect data (after hospital discharge) on duration of ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Ventilator free days
Duration of time off of invasive mechanical ventilation during the ICU stay
Measured: We will collect data (after hospital discharge) on duration of intubation for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Adverse events
Frequency of morbidities, e.g. unplanned extubation, failed extubation, cardiorespiratory arrest events, unintentional dislodgment of other lines/tubes, re-admission to the hospital/ICU within 24 hours of discharge/transfer.
Measured: We will collect data (after hospital discharge) on morbidity events for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
State behavioral scale (SBS) scores
Difference between the desired SBS score and the recorded SBS score
Measured: We will collect data (after hospital discharge) on documented SBS scores for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Cornell Assessment of Pediatric Delirium (CAPD) scores
CAPD scores for patients during their ICU stay
Measured: We will collect data (after hospital discharge) on documented CAPD scores for each ICU patient admitted between Aug 2019 - Feb 2020 (post-intervention group only).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Aug 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilesh M. Mehta, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263662
- Sponsor's protocol ID
- IRB-P00032707
- Status last verified
- Jan 2021
- First submitted
- 5 Feb 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a New Analgesia-sedation Algorithm in the Pediatric Intensive Care Unit to Reduce Overall Benzodiazepine Usage
- ClinicalTrials.gov ID
- NCT04263662
- Acronym / sponsor ID
- IRB-P00032707
- Conditions
- Mechanical Ventilation, Sedation
- Keywords
- Analgesia, Sedation, Dexmedetomidine, Mechanical Ventilation, Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to develop and implement an evidence-based analgesia-sedation algorithm in the pediatric intensive care unit (PICU) using quality improvement and implementation science methodology. The analgesia-sedation protocol will be implemented for patients admitted to the pediatric ICU who require mechanical ventilation for greater than 24 hours. Specifically, we will examine the impact of this implementation on total benzodiazepine usage, ICU length of stay, and ventilator free days, using a pre- and post- algorithm implementation comparative design.
Detailed description
Study Design and exposures:
- Development of an evidence-based analgesia-sedation algorithm for mechanically ventilated children using an iterative, multidisciplinary collaborative effort.
- Exposure: Implementation of the analgesia-sedation algorithm using standard quality improvement (QI) methodology. This will include education, awareness, wash-in phases followed by actual implementation with support. We will use a before-after comparison design.
Patients will be eligible if they are admitted to the medical and multidisciplinary (medical/surgical) ICUs at Boston Children's Hospital and require mechanical ventilatory support for greater than 24 hours.
Study period: Eligible patients who are admitted to the ICUs between August 1st 2017 - February 28th 2018 (pre-implementation) and August 1st 2019 - February 28th 2020 (post-implementation) will be enrolled.
Data collection: Retrospective chart review, with manual data entry in REDCap. Pre-intervention data will be collected starting July 2019. After the intervention begins in July 2019, data collection will occur monthly with the intent of collecting compliance data through analyzing usage of a new electronic medical record order set designed specifically for this intervention and feeding that back to staff members via electronic communication and meeting presentations in order to assess barriers to implementation of the new algorithm. Prospective post-intervention data collection will begin in September 2019 and end in March 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-algorithm | – | –Patients admitted to the pediatric ICU who are intubated for greater than 24 hours prior to implementation of an analgesia-sedation algorithm. |
| Post-algorithm | – | Other: Analgesia-Sedation algorithmPatients admitted to the pediatric ICU who are intubated for greater than 24 hours after implementation of an analgesia-sedation algorithm. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients admitted to the ICU who receive invasive mechanical ventilation via an endotracheal or nasotracheal tube and are potentially eligible to follow the analgesia-sedation algorithm.
Key inclusion criteria (2 listed)
- Admitted to the pediatric ICU between August 1st 2017 - February 28th 2018 and August 1st 2019 - February 28th 2020
- Intubated for greater than 24 hours will be eligible
Key exclusion criteria (4 listed)
- Ventilated via a tracheostomy at the time of admission
- Pre-admission documentation of dexmedetomidine allergy
- Receiving a midazolam infusion for greater than 4 hours at the time of admission
- Admitted to the ICU for initiation of the rapid-escalation midazolam protocol for status epilepticus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesia-Sedation algorithmThe analgesia-sedation algorithm is a suggested protocol for approach to providing analgesia and sedation to patients admitted to the pediatric ICU who are newly intubated. The approach focuses on using dexmedetomidine as the primary sedative, non-opioids as the primary analgesia, then stepwise approach to adding in adjunctives (e.g. opioids, non-benzodiazepines) with the intention of minimizing benzodiazepine exposure and utilizing minimal-dose effective analgesia/sedative dosing. | Other | Post-algorithm |
Primary outcome
Benzodiazepine exposure
Time frame: We will collect data (after hospital discharge) on amount of benzodiazepine administration in their ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Total exposure of benzodiazepines (midazolam, lorazepam, diazepam) measured per kilogram of weight over the patient's duration of ICU stay.
6 secondary outcomes
Opioid exposure
Time frame: We will collect data (after hospital discharge) on amount of opioid administration in their ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
ICU length of stay
Time frame: We will collect data (after hospital discharge) on duration of ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Ventilator free days
Time frame: We will collect data (after hospital discharge) on duration of intubation for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Adverse events
Time frame: We will collect data (after hospital discharge) on morbidity events for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
State behavioral scale (SBS) scores
Time frame: We will collect data (after hospital discharge) on documented SBS scores for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).
Cornell Assessment of Pediatric Delirium (CAPD) scores
Time frame: We will collect data (after hospital discharge) on documented CAPD scores for each ICU patient admitted between Aug 2019 - Feb 2020 (post-intervention group only).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Sedation, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benzodiazepine exposure (time frame: We will collect data (after hospital discharge) on amount of benzodiazepine administration in their ICU stay for each ICU patient admitted between Aug 2017 - Feb 2018 (pre-intervention group), and Aug 2019 - Feb 2020 (post-intervention group).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.