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Sedation Management in Pediatric Patients Supported on Mechanical Ventilation

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ClinicalTrials.gov Identifier: NCT00142766
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : October 7, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Behavioral: Nurse Implemented Goal-Directed Comfort Algorithm Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sedation Management in Pediatric Patients Supported on Mechanical Ventilation
Study Start Date : February 2004
Primary Completion Date : July 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: Nurse Implemented Goal-Directed Comfort Algorithm
    See description

Outcome Measures

Primary Outcome Measures :
  1. Duration of Mechanical Ventilation [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Time to Recovery of Lung Injury [ Time Frame: 28 days ]
  2. Duration of Weaning from Mechanical Ventilation [ Time Frame: 28 days ]
  3. Occurrence of Adverse Events [ Time Frame: 28 days ]
  4. Total Exposure to Comfort Medications [ Time Frame: 28 days ]
  5. Occurrence of Iatrogenic Abstinence Syndrome [ Time Frame: 28 days ]
  6. PICU Length of Stay [ Time Frame: 28 days ]
  7. Barriers to Successful Implementation of the Intervention [ Time Frame: 28 days ]
  8. PICU costs [ Time Frame: 28 days ]

Eligibility Criteria

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142766

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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Gustavus and Louise Pfeiffer Research Foundation
Principal Investigator: Martha AQ Curley, RN PhD FAAN Boston Children’s Hospital
More Information

Responsible Party: Martha Curley, Ellen and Robert Kapito Professor in Nursing Science, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00142766     History of Changes
Other Study ID Numbers: R21HD045020 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by Martha Curley, University of Pennsylvania:
Mechanical ventilation
Critical illness
Opioid Withdrawal
Benzodiazepine Withdrawal

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