Daily Sedative Interruption, Mechanical Ventilation, Sedation, Sedation Protocols, Sedation Strategies
Conditions
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.
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.
Interventions
OTHERSedation Interruption Protocol
OTHERStandard Sedation Protocol
Sponsors
Davinia Withington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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. |
| Adherence Rate | At 30 days | — |
| Reasons for non-participation | At 30 days | — |
| Duration of mechanical ventilation in hours. | intraoperative | Total number of hours between the moment patient was intubated to the moment of extubation. |
Countries
Canada
Contacts
Primary ContactYasser Kazzaz, MBBS, FRCPC, FAAP
Backup ContactDavinia Withington, BM FRCA MRCP
Outcome results
None listed