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Sedation Management in Pediatric Patients Supported on Mechanical Ventilation

NCT00142766 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2015-10-07

No results posted yet for this study

Summary

The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an integral part of pediatric critical care, analgesic and sedative use in this patient population is associated with injury; specifically, comfort medications may depress spontaneous ventilation and prolong the duration of mechanical ventilation. Additionally, drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome (chemical withdrawal) when the patient no longer requires sedation. Alternatively, suboptimal comfort management contributes to the patient not breathing synchronously with the ventilator and/or self-removal of breathing tubes.

Our group has developed and validated a nurse-implemented sedation algorithm (set of specific instructions) to guide titration of comfort medications that may optimize patient comfort and reduce the risk of under-medication, but this algorithm needs to be evaluated further. We hypothesize that pediatric patients managed per sedation protocol will experience fewer days of mechanical ventilation than patients receiving usual care. This research has the potential of revolutionizing sedation practices that are driven by and synchronized to patient needs.

Conditions

Interventions

BEHAVIORAL

Nurse Implemented Goal-Directed Comfort Algorithm

See description

Sponsors & Collaborators

  • Gustavus and Louise Pfeiffer Research Foundation

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Martha AQ Curley, RN PhD FAAN · Boston Children's Hospital

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
2004-02-29
Primary Completion
2006-07-31
Completion
2007-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00142766 on ClinicalTrials.gov