Clinical trial NCT02829710: Implementation and Evaluation of a Pediatric Nurse-driven Sedation Protocol in a PICU
Official title: Implementation and Evaluation of a Paediatric Nurse-driven Sedation Protocol in a Paediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Deep Sedation
Keywords: Analgesia
intensive care units
clinical protocol
deep sedation
nursing assessment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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, 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.


Eligibility criteria: Inclusion Criteria:

* Mechanically-ventilated patients aged from 0 to 18 years receiving sedation for more than 24 hours

Exclusion Criteria:

* Patients with tracheostomy

Primary outcomes:
measure: Duration of mechanical ventilation (days)
timeFrame: Over the PICU stay of each child (Day 5)
Secondary outcomes:
measure: Total doses of sedatives (unit/kg)
timeFrame: Over the PICU stay of each child (Day 5)
measure: Occurrence of withdrawal symptoms
timeFrame: Over the PICU stay of each child (Day 5)
measure: Length of PICU stay (days)
timeFrame: Over the PICU stay of each child (Day 5)
Other outcomes:
Locations:
city: Bron
country: France
facility: service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel
Study officials:
affiliation: service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon
name: Fabienne Bordet, MD
role: PRINCIPAL_INVESTIGATOR
References: