Sedation Management in Pediatric Patients Supported on Mechanical Ventilation

This study has been completed.
Sponsor:
Collaborator:
Gustavus and Louise Pfeiffer Research Foundation
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00142766
First received: August 31, 2005
Last updated: December 4, 2008
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Respiratory Failure
Behavioral: Nurse Implemented Goal-Directed Comfort Algorithm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sedation Management in Pediatric Patients Supported on Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Duration of Mechanical Ventilation [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Recovery of Lung Injury [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Duration of Weaning from Mechanical Ventilation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Occurrence of Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Total Exposure to Comfort Medications [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Occurrence of Iatrogenic Abstinence Syndrome [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • PICU Length of Stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Barriers to Successful Implementation of the Intervention [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • PICU costs [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: February 2004
Study Completion Date: March 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Nurse Implemented Goal-Directed Comfort Algorithm
    See description
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intubated and mechanically ventilated
  • Pulmonary disease

Exclusion Criteria:

  • Less than or equal to 2 weeks of age or 42 weeks corrected gestational age
  • Greater than 18 years of age
  • Intubated and mechanically ventilated for immediate post-operative care and stabilization
  • Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
  • Critical airway (e.g. post laryngotracheal reconstruction)
  • Ventilator dependent (including noninvasive) on PICU admission (chronic assisted ventilation)
  • Neuromuscular respiratory failure
  • Spinal cord injury above the lumbar region
  • Managed by patient controlled analgesia (PCA)or epidural catheter
  • Known allergy to any of the study medications (Morphine,Methadone, Midazolam, Lorazepam)
  • Family/Medical team have decided not to provide full support(patient treatment considered futile)
  • Previously enrolled into the current study or enrolled in any other sedation clinical trial concurrently or within the last 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142766

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Gustavus and Louise Pfeiffer Research Foundation
Investigators
Principal Investigator: Martha AQ Curley, RN PhD FAAN Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Martha A.Q. Curley, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00142766     History of Changes
Other Study ID Numbers: R21HD045020
Study First Received: August 31, 2005
Last Updated: December 4, 2008
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Sedation
Mechanical ventilation
Critical illness
Analgesic
Opioid Withdrawal
Benzodiazepine Withdrawal
Nurse

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014