Pilot Study for Sedation Interruption in Children

April 23, 2015 updated by: Davinia Withington

Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study

The purpose of this study is to estimate the hypothesized benefit of sedation interruption protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate recruitment rates, and adherence rates of such protocol.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective single-center, superiority, open randomized controlled trial comparing sedation interruption protocol and routine continuous sedation in mechanically ventilation (MV) children.

The study will be conducted in the twelve beds Pediatric Intensive Care Unit (PICU) at the Montreal Children's Hospital, a pediatric tertiary care and teaching hospital.

Patients will be enrolled prospectively within 24 hours of intubation and MV. After obtaining written consent patients will then be randomized to interrupted sedation or standard sedation protocol. The investigators will randomize using a computer-generated sequence of random numbers.

A Sedation protocol will be used for both groups to adjust continuous infusions of sedatives/analgesics to a targeted Comfort-Behavior scale. In the intervention group, sedation infusions will be interrupted daily at 8:00 AM, this interruption will be continued until the patient is under-sedated according to the Comfort Behavior scale goals or in the presence of symptoms of hemodynamic instability or respiratory distress. Then the patient will receive a bolus of sedation and the infusion will be restarted at a dose 50% less than the previous dose to return to the Comfort Score goal.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Recruiting
        • Montreal Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intubated and mechanically ventilated patients due to respiratory failure of multiple etiologies or after major surgical procedures for more than 24 hours.
  • Sedation managed by benzodiazepines and opioids infusions

Exclusion Criteria:

  • If sedation is required as part of medical management (Pulmonary hypertension, Increase intracranial pressure, Seizures
  • Trauma & burn admissions
  • Patients resuscitated from cardiac arrest
  • Allergy to sedation (midazolam)
  • Allergy to analgesia (fentanyl, morphine)
  • Difficult airway including post-operative airway surgeries. (As deemed by ICU physician in charge)
  • High frequency oscillator
  • Special gas as inhaled nitric oxide, or isoflurane.
  • Chronic ventilatory support
  • Neuromuscular diseases
  • Corrected Gestational age less than 37 weeks.
  • Patients not expected to survive to discharge as per attending physician.
  • Palliative care patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sedation Interruption Protocol + standard sedation protocol
Nurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia
Other: Sedation Interruption Protocol
Active Comparator: Standard sedation protocol
Nurse directed protocol for administering sedation and/or analgesia.
Other: Standard Sedation Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: At 30 days
The number of eligible patients who provided informed consent to participate in the study divided by the total number of eligible patients who were asked for informed consent during the pilot study period over 1 year period.
At 30 days
Adherence Rate
Time Frame: At 30 days
At 30 days
Reasons for non-participation
Time Frame: At 30 days
At 30 days
Duration of mechanical ventilation in hours.
Time Frame: intraoperative
Total number of hours between the moment patient was intubated to the moment of extubation.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Davinia Withington

Investigators

  • Principal Investigator: Conall Francoeur, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Christina Maratta, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Maryse Dagenais, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 14-011-PED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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