Implementation and Evaluation of a Pediatric Nurse-driven Sedation Protocol in a PICU (SEDATIDE)

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.

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 Overview

• Status: Completed
• Conditions: Analgesia; Deep Sedation
• Intervention / Treatment: Behavioral: Nurse-driven sedation protocol

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with tracheostomy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Nurse-driven sedation protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of mechanical ventilation (days)	Over the PICU stay of each child (Day 5)

Secondary Outcome Measures

Outcome Measure	Time Frame
Total doses of sedatives (unit/kg)	Over the PICU stay of each child (Day 5)
Occurrence of withdrawal symptoms	Over the PICU stay of each child (Day 5)
Length of PICU stay (days)	Over the PICU stay of each child (Day 5)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Fabienne Bordet, MD, service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Analgesia; intensive care units; deep sedation; nursing assessment; clinical protocol
• Other Study ID Numbers: 69HCL15_0312