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Pilot Study for Sedation Interruption in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426320
Recruitment Status : Unknown
Verified April 2015 by Davinia Withington, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Recruiting
First Posted : April 24, 2015
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Davinia Withington, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Daily Sedative Interruption Sedation Strategies Sedation Protocols Mechanical Ventilation Sedation Other: Sedation Interruption Protocol Other: Standard Sedation Protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study
Study Start Date : April 2015
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

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



Primary Outcome Measures :
  1. 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.

  2. Adherence Rate [ Time Frame: At 30 days ]
  3. Reasons for non-participation [ Time Frame: At 30 days ]
  4. Duration of mechanical ventilation in hours. [ Time Frame: intraoperative ]
    Total number of hours between the moment patient was intubated to the moment of extubation.



Information from the National Library of Medicine

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

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.

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): NCT02426320


Contacts
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Contact: Yasser Kazzaz, MBBS, FRCPC, FAAP 6479892770 yasser.md@gmail.com
Contact: Davinia Withington, BM FRCA MRCP davinia.withington@mcgill.ca

Locations
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Canada, Quebec
Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
Davinia Withington
Investigators
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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:

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Responsible Party: Davinia Withington, Pediatric Anesthesiologist and Intensivist, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02426320    
Other Study ID Numbers: 14-011-PED
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015