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Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)

NCT00814099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2449

Last updated 2026-05-01

No results posted yet for this study

Summary

People with acute respiratory failure usually require the use of an artificial breathing machine, known as a mechanical ventilator. Sedative medications, which help keep people calm and reduce anxiety, are often prescribed for children who are on mechanical ventilators. However, the longer that sedative medications are used, the longer a child may need to remain on mechanical ventilation. This study will evaluate the effectiveness of a team approach to sedation management that aims to reduce the number of days that children with acute respiratory failure require mechanical ventilation.

Conditions

  • Respiratory Insufficiency
  • Respiratory Distress Syndrome, Newborn
  • Lung Diseases

Interventions

BEHAVIORAL

Team approach to sedation management

The team approach to sedation management includes the following: * Team education and consensus on the use of sedatives * Team identification of the patient's trajectory of illness and daily prescription of a sedation goal * A nurse-implemented goal-directed comfort algorithm that guides moment-to-moment titration of opioids and benzodiazepines * Team feedback on sedation management performance

BEHAVIORAL

Usual approach to sedation management

The pediatric ICU will continue its usual approach to sedation management.

Sponsors & Collaborators

Principal Investigators

  • Martha A.Q. Curley, RN, PhD · University of Pennsylvania

  • David Wypij, PhD · Director, Statistics and Data Coordinating Center; Children's Hospital Boston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814099 on ClinicalTrials.gov