The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives.
The main question\[s\] it aims to answer are:
* Will people join the study? (recruitment) * Will participants finish the study? * Will healthcare teams accept the study procedures?
Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.
Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24 hours
Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible)
Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas analyzer function)
Family history or personal history of malignant hyperthermia (MH)
Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas
Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction)
Parallel
Isoflurane Inhalant Product
DrugIsoflurane will be administered using an inhalation device
Participant recruitment
Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years).
Protocol adherence
The frequency (%) of randomized patients who remain within their designated trial arm and cross-overs. Cross overs may occur from i) drug allergy (rare \<0.1%), ii) clinical reason, iii) equipment issues, and iv) health team discomfort using a new intervention.
Attrition
The frequency (%) of randomized patients who are lost to follow up prior to completion of all study outcome measures and the reasons for no follow-up will be documented. Expected loss to follow-up can occur due to i) inter-facility transfers, ii) patient/family withdrawal from the trial, iii) lack of interest in long-term follow-up.
Safety/adverse event rate
Adverse events that are assess as related (possibly, probably or definitely) to study intervention, standard of care, or study equipment will be reported. Adverse events that are assess as unrelated to study intervention, standard of care or study equipment will not be reported. Adverse events will be captured from the time of consent until the time of study completion.
Healthcare team satisfaction
All health team members (physicians, nurses and respiratory therapists) will be surveyed daily for up to 3 days in both study arms using a 5-point Likert scale satisfaction score. Free text comments will be allowed to better understand barriers and facilitators.
Feasibility of collecting delirium scores
Proportion of participants who complete delirium (Cornell Assessment of Pediatric Delirium (CAPD)) and coma (Richmond Agitation Sedation Scale (RASS) or COMFORT Behavioural Scale (COMFORT-B)) assessments twice a day.
Delirium-free Coma-free days
The number of full days participants do not experience coma or delirium as assessed by RASS or COMFORT-B for coma and CAPD for delirium.
Anti-psychotic drug use
The administration of anti-psychotic drugs will be captured from baseline until day 28.
Sedative drug use
The administration of sedative drugs will be captured from baseline until day 28.
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Sunnybrook Health Sciences Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
