Pilot Study for Sedation Interruption in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Daily Sedative Interruption, Sedation Strategies, Sedation Protocols, Mechanical Ventilation, Sedation

Intervention / Treatment
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* Other: Sedation Interruption Protocol
* Other: Standard Sedation Protocol


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | 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 |  | At 30 days | 
| Reasons for non-participation |  | At 30 days | 
| Duration of mechanical ventilation in hours. | Total number of hours between the moment patient was intubated to the moment of extubation. | intraoperative |