AnalgesiaSEDATIDENCT02829710
Implementation and Evaluation of a Pediatric Nurse-driven Sedation Protocol in a PICU
An observational study of Analgesia and Deep Sedation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Management of analgesia and sedation is an integral component of the medical care of a critically-ill child. Its role is to assure comfort and safety to a patient undergoing painful cares and technical procedures; it can also be, in particular situations like acute respiratory distress syndrome or acute brain injury… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Analgesia, Deep Sedation
- What is being tested?
- Nurse-driven sedation protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Apr 2015
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children aged from 0 to 18 years, requiring mechanical ventilation for at least 24 hours admitted in a PICU between January 2013 and December 2013 and between May 2014 and March 2015.
Who may be able to join
- Mechanically-ventilated patients aged from 0 to 18 years receiving sedation for more than 24 hours
Who cannot join
- Patients with tracheostomy
Trial locations and contacts
1 site in 1 country.
France1 site
service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel
Bron, 69677
About this study
Official title: Implementation and Evaluation of a Paediatric Nurse-driven Sedation Protocol in a Paediatric Intensive Care Unit
Management of analgesia and sedation is an integral component of the medical care of a critically-ill child. Its role is to assure comfort and safety to a patient undergoing painful cares and technical procedures; it can also be, in particular situations like acute respiratory distress syndrome or acute brain injury, a full processing treatment.
Sedation involves, most of the time, the association of an opioid and a sedative. The use of these drugs is difficult in children, because of a specific metabolism, inducing tolerance and withdrawal in case of prolonged administration.
Read more
The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to avoid inadequate sedation.
Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation, longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the treatment to the patient's need and permit a reduction in the duration of mechanical ventilation.
The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric intensive care unit on duration of mechanical ventilation, total doses and duration of medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of ventilator-associated-pneumonia and occurrence of withdrawal.
- Conditions
- Analgesia, Deep Sedation
- Being tested
- Nurse-driven sedation protocol
- Keywords
- Analgesia, intensive care units, clinical protocol, deep sedation, nursing assessment
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-driven sedation protocolBehavioural
The nurse-driven sedation protocol included the COMFORT-B scale. Initial doses were chosen by the physicians then all changes were made by the nurses with the aim of attaining an optimal range of analgesia and sedation, which was defined as values from 11 to 17 on the COMFORT-B score.
| Study group | Role | What they receive |
|---|---|---|
| group 1 : pre implementation group | All children aged less than 18 years, requiring mechanical ventilation for at least 24 hours and admitted in PICU between January 2013 and December 2013. Prior to implementation of the protocol, analgesia and sedation were managed by the attending physician's order. | |
| group 2 : post implementation group | All children aged less than 18 years, requiring mechanical ventilation for at least 24 hours and admitted in PICU between May 2014 and March 2015.
Nurses managed analgesia and sedation following an algorithm, including COMFORT-B scale. Receives: Behavioral: Nurse-driven sedation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation (days)
Measured: Over the PICU stay of each child (Day 5)
Secondary outcomes (3)
Total doses of sedatives (unit/kg)
Measured: Over the PICU stay of each child (Day 5)
Occurrence of withdrawal symptoms
Measured: Over the PICU stay of each child (Day 5)
Length of PICU stay (days)
Measured: Over the PICU stay of each child (Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Bordet, MD, Principal investigator, service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829710
- Sponsor's protocol ID
- 69HCL15_0312
- Acronym
- SEDATIDE
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Paediatric Nurse-driven Sedation Protocol in a Paediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02829710
- Acronym / sponsor ID
- SEDATIDE / 69HCL15_0312
- Conditions
- Analgesia, Deep Sedation
- Keywords
- Analgesia, intensive care units, clinical protocol, deep sedation, nursing assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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.
Management of analgesia and sedation is an integral component of the medical care of a critically-ill child. Its role is to assure comfort and safety to a patient undergoing painful cares and technical procedures; it can also be, in particular situations like acute respiratory distress syndrome or acute brain injury, a full processing treatment.
Sedation involves, most of the time, the association of an opioid and a sedative. The use of these drugs is difficult in children, because of a specific metabolism, inducing tolerance and withdrawal in case of prolonged administration.
The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to avoid inadequate sedation.
Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation, longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the treatment to the patient's need and permit a reduction in the duration of mechanical ventilation.
The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric intensive care unit on duration of mechanical ventilation, total doses and duration of medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of ventilator-associated-pneumonia and occurrence of withdrawal.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 : pre implementation group | – | –All children aged less than 18 years, requiring mechanical ventilation for at least 24 hours and admitted in PICU between January 2013 and December 2013. Prior to implementation of the protocol, analgesia and sedation were managed by the attending physician's order. |
| group 2 : post implementation group | – | Behavioral: Nurse-driven sedation protocolAll children aged less than 18 years, requiring mechanical ventilation for at least 24 hours and admitted in PICU between May 2014 and March 2015. Nurses managed analgesia and sedation following an algorithm, including COMFORT-B scale. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children aged from 0 to 18 years, requiring mechanical ventilation for at least 24 hours admitted in a PICU between January 2013 and December 2013 and between May 2014 and March 2015.
Key inclusion criteria (1 listed)
- Mechanically-ventilated patients aged from 0 to 18 years receiving sedation for more than 24 hours
Key exclusion criteria (1 listed)
- Patients with tracheostomy
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 |
|---|---|---|
| Nurse-driven sedation protocolThe nurse-driven sedation protocol included the COMFORT-B scale. Initial doses were chosen by the physicians then all changes were made by the nurses with the aim of attaining an optimal range of analgesia and sedation, which was defined as values from 11 to 17 on the COMFORT-B score. | Behavioural | group 2 : post implementation group |
Primary outcome
Duration of mechanical ventilation (days)
Time frame: Over the PICU stay of each child (Day 5)
3 secondary outcomes
Total doses of sedatives (unit/kg)
Time frame: Over the PICU stay of each child (Day 5)
Occurrence of withdrawal symptoms
Time frame: Over the PICU stay of each child (Day 5)
Length of PICU stay (days)
Time frame: Over the PICU stay of each child (Day 5)
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 12 Jul 2016.
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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.
Fabienne Bordet, MD principal investigator
service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon
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 Analgesia and Deep Sedation, run by Hospices Civils de Lyon at 1 site 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 1 inclusion and 1 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 12 Jul 2016. 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 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?
Duration of mechanical ventilation (days) (time frame: Over the PICU stay of each child (Day 5)). 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 12 Jul 2016.