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

NCT02829710 | Completed

• 1 other identifier: 69HCL15_0312
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Deep Sedation

Keywords

Analgesia; intensive care units; clinical protocol; deep sedation; nursing assessment

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation (days)

  Over the PICU stay of each child (Day 5)

Secondary Outcomes (3)

• 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)

Study Arms (2)

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

Interventions

Nurse-driven sedation protocol BEHAVIORAL

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.

group 2 : post implementation group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients with tracheostomy

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69677, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabienne Bordet, MD

  service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 12, 2016
• Study Start: January 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 12, 2016

Record last verified: 2016-06

Locations

FR (1)