NCT00142766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2004

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

August 31, 2005

Last Update Submit

October 5, 2015

Conditions

Respiratory Failure

Keywords

SedationMechanical ventilationCritical illnessAnalgesicOpioid WithdrawalBenzodiazepine WithdrawalNurse

Outcome Measures

Primary Outcomes (1)

  • Duration of Mechanical Ventilation

    28 days

Secondary Outcomes (8)

  • Time to Recovery of Lung Injury

    28 days

  • Duration of Weaning from Mechanical Ventilation

    28 days

  • Occurrence of Adverse Events

    28 days

  • Total Exposure to Comfort Medications

    28 days

  • Occurrence of Iatrogenic Abstinence Syndrome

    28 days

  • +3 more secondary outcomes

Interventions

Nurse Implemented Goal-Directed Comfort AlgorithmBEHAVIORAL

See description

Eligibility Criteria

Age2 Weeks - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Intubated and mechanically ventilated
  • Pulmonary disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (1)

  • Curley MAQ, Gedeit RG, Dodson BL, Amling JK, Soetenga DJ, Corriveau CO, Asario LA, Wypij D; RESTORE Investigative Team. Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial. Trials. 2018 Dec 17;19(1):687. doi: 10.1186/s13063-018-3075-8.

    PMID: 30558653DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyCritical Illness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martha AQ Curley, RN PhD FAAN

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ellen and Robert Kapito Professor in Nursing Science

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

February 1, 2004

Primary Completion

July 1, 2006

Study Completion

March 1, 2007

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

US(3)