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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 May 2015 |
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Main ID: |
NCT02426320 |
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Date of registration:
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21/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pilot Study for Sedation Interruption in Children
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Scientific title:
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Daily Interruption of Sedative Infusions in Mechanically Ventilated Children: A Randomized Pilot Study |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02426320 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Conall Francoeur |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University Health Center |
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Name:
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Christina Maratta |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University Health Center |
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Name:
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Maryse Dagenais |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University Health Center |
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Name:
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Yasser Kazzaz, MBBS, FRCPC, FAAP |
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Address:
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Telephone:
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6479892770 |
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Email:
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yasser.md@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sedation
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Sedation Protocols
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Daily Sedative Interruption
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Mechanical Ventilation
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Sedation Strategies
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Intervention(s)
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Other: Standard Sedation Protocol
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Other: Sedation Interruption Protocol
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Primary Outcome(s)
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Duration of mechanical ventilation in hours.
[Time Frame: intraoperative]
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Reasons for non-participation
[Time Frame: At 30 days]
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Recruitment rate
[Time Frame: At 30 days]
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Adherence Rate
[Time Frame: At 30 days]
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Secondary ID(s)
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14-011-PED
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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