Mechanical VentilationSEDATIDE2NCT07038850
Improving Adherence to the Sedation-analgesia Protocol in Pediatric Intensive Care
A study testing Multimodal nurse training about nurse driven sedation-analgesia protocol in people with Mechanical Ventilation and Analgesia, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Sedation-analgesia is a major concern in the management of children in pediatric intensive care units (PICUs). International guidelines recommend the use of sedation-analgesia protocols, as their implementation has already proven effective in pediatrics. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Mechanical Ventilation, Analgesia, Nurse Training
- What is being tested?
- Multimodal nurse training about nurse driven sedation-analgesia protocol
- How many people
- 285 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Nov 2020to 31 Mar 2023
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients aged 0 to 18 years
- admitted to the PICU
- requiring mechanical ventilation
- receiving continuous sedation for more than 24 hour
Who cannot join
- patients requiring mechanical ventilation for more than 15 days
- transferred from another unit where sedation had already been initiated
- patients under sedation as part of withdrawing and withholding life-sustaining treatment
- deceased patients
- preexisting tracheostomies
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de réanimation pédiatrique du CHU de Lyon
Lyon, 69000
Service de réanimation pédiatrique du CHU de Nantes
Nantes, 44000
About this study
Official title: Improving Caregivers' Adherence to a Sedation-analgesia Protocol Managed by Pediatric Intensive Care Nurses: a Quality Approach Program
Sedation-analgesia is a major concern in the management of children in pediatric intensive care units (PICUs). International guidelines recommend the use of sedation-analgesia protocols, as their implementation has already proven effective in pediatrics. However, maintaining their long-term application remains a challenge. Indeed, healthcare teams adherence to these protocols tends to decrease over time, thereby compromising their long-term impact. This study aims to evaluate the impact of multimodal nurses training on improving and sustaining adherence to sedation-analgesia protocols. This is a non-randomized, before-and-after interventional prospective study conducted in two mixed pediatric intensive care units (Lyon and Nantes). The investigators seek to evaluate sedation practices before and after the implementation of specific multimodal training for nurses on the sedation-analgesia protocol. The primary outcome is protocol adherence. Secondary outcomes include the duration of mechanical ventilation and PICU stay, the number of daily COMFORT-B score assessments, total medication doses, the incidence of ventilator-associated pneumonia, and a qualitative analysis of non-adherence factors.
- Conditions
- Mechanical Ventilation, Analgesia, Nurse Training
- Being tested
- Multimodal nurse training about nurse driven sedation-analgesia protocol
- Keywords
- Nurse driven sedation-analgesia protocols, Adherence to protocol, Pediatric intensive care
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal nurse training about nurse driven sedation-analgesia protocolOther
The training program for nursing staff in the use of the sedation-analgesia protocol includes 3 stages:
- Initial training: e-learning module to be validated
- Feedback session: sessions in small groups of 5 to 6 participants, led by a nurse trainer, allowing interprofessional transmission (questions/answers and critical analyzes of sedation collection sheets).
- Bedside rehearsal: individual practice of the sedation-analgesia protocol at the patient's bedside under the supervision of a doctor or nurse trainer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol adherence before and after nurse training: daily percentage of therapeutic adjustments in compliance with the sedation-analgesia protocol.
Sedation management is considered adequate (when dose increases, decreases, or maintenance are appropriate based on the COMFORT-B score), and inadequate (when adjustments are inappropriate or if the COMFORT-B score is not recorded despite a prescribed target). Cases where no target score is prescribed are excluded from the adherence analysis.
Measured: Compliance of therapeutic adjustments with the sedation-analgesia protocol is evaluated over the entire duration of mechanical ventilation. Daily , from initiation of mechanical ventilation until extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start2 Nov 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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 Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Fabienne BORDET Dr Fabienne BORDET, Doctor, Principal investigator, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038850
- Sponsor's protocol ID
- 69HCL18_0108
- Acronym
- SEDATIDE2
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Caregivers' Adherence to a Sedation-analgesia Protocol Managed by Pediatric Intensive Care Nurses: a Quality Approach Program
- ClinicalTrials.gov ID
- NCT07038850
- Acronym / sponsor ID
- SEDATIDE2 / 69HCL18_0108
- Conditions
- Mechanical Ventilation, Analgesia, Nurse Training
- Keywords
- Nurse driven sedation-analgesia protocols, Adherence to protocol, Pediatric intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 Jun 2025 (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.
Sedation-analgesia is a major concern in the management of children in pediatric intensive care units (PICUs). International guidelines recommend the use of sedation-analgesia protocols, as their implementation has already proven effective in pediatrics. However, maintaining their long-term application remains a challenge. Indeed, healthcare teams adherence to these protocols tends to decrease over time, thereby compromising their long-term impact. This study aims to evaluate the impact of multimodal nurses training on improving and sustaining adherence to sedation-analgesia protocols. This is a non-randomized, before-and-after interventional prospective study conducted in two mixed pediatric intensive care units (Lyon and Nantes). The investigators seek to evaluate sedation practices before and after the implementation of specific multimodal training for nurses on the sedation-analgesia protocol. The primary outcome is protocol adherence. Secondary outcomes include the duration of mechanical ventilation and PICU stay, the number of daily COMFORT-B score assessments, total medication doses, the incidence of ventilator-associated pneumonia, and a qualitative analysis of non-adherence factors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- patients aged 0 to 18 years
- admitted to the PICU
- requiring mechanical ventilation
- receiving continuous sedation for more than 24 hour
Key exclusion criteria (5 listed)
- patients requiring mechanical ventilation for more than 15 days
- transferred from another unit where sedation had already been initiated
- patients under sedation as part of withdrawing and withholding life-sustaining treatment
- deceased patients
- preexisting tracheostomies
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 |
|---|---|---|
| Multimodal nurse training about nurse driven sedation-analgesia protocolThe training program for nursing staff in the use of the sedation-analgesia protocol includes 3 stages: 1. Initial training: e-learning module to be validated 2. Feedback session: sessions in small groups of 5 to 6 participants, led by a nurse trainer, allowing interprofessional transmission (questions/answers and critical analyzes of sedation collection sheets). 3. Bedside rehearsal: individual practice of the sedation-analgesia protocol at the patient's bedside under the supervision of a doctor or nurse trainer. | Other | – |
Primary outcome
Protocol adherence before and after nurse training: daily percentage of therapeutic adjustments in compliance with the sedation-analgesia protocol.
Time frame: Compliance of therapeutic adjustments with the sedation-analgesia protocol is evaluated over the entire duration of mechanical ventilation. Daily , from initiation of mechanical ventilation until extubation
Sedation management is considered adequate (when dose increases, decreases, or maintenance are appropriate based on the COMFORT-B score), and inadequate (when adjustments are inappropriate or if the COMFORT-B score is not recorded despite a prescribed target). Cases where no target score is prescribed are excluded from the adherence analysis.
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 26 Jun 2025.
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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.
Dr Fabienne BORDET Dr Fabienne BORDET, Doctor principal investigator
HCL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal nurse training about nurse driven sedation-analgesia protocol in people with Mechanical Ventilation and Analgesia, run by Hospices Civils de Lyon at 2 sites in France.
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 4 inclusion and 5 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Protocol adherence before and after nurse training: daily percentage of therapeutic adjustments in compliance with the sedation-analgesia protocol. (time frame: Compliance of therapeutic adjustments with the sedation-analgesia protocol is evaluated over the entire duration of mechanical ventilation. Daily , from initiation of mechanical ventilation until extubation). 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 26 Jun 2025.