Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children
Conditions
Brief summary
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.
Interventions
Isoflurane will be administered using an inhalation device
Sponsors
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an open label trial that will be blinded to the outcome assessor and data analyst, but not to the clinical team. Blinding is not feasible for the clinical team and patient / family given the easily identifiable differences in the nature of the essential equipment used between the two arms.
Intervention model description
Pilot, multicenter, vanguard randomized controlled trial (RCT) to assess the feasibility of accruing patients, delivering the intervention of inhaled sedatives, and ascertaining outcomes in preparation for a definitive trial to evaluate if inhaled sedatives (intervention) compared to IV agents (comparator) improves delirium (outcome) in mechanically ventilated children (population).
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible)
Exclusion criteria
1. Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas analyzer function) 2. Family history or personal history of malignant hyperthermia (MH) 3. Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas 4. Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction) 5. Moribund with expected survival \< 24h 6. Known pregnancy or lactation 7. Suspected or evidence of high intracranial pressure (ICP) 8. Not a 'closed ventilator circuit' with potential for gas leak (e.g. uncuffed ETT, bronchopleural fistula, tracheal/trachea-esophageal fistulas, or other sources of "gas leak" from patient circuit that cannot be removed) 9. Prior enrollment in the ABOVE trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant recruitment | 2 years | Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protocol adherence | 28 days | 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 | 3 years | 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 | From date of consent until the date of resolution or date of death from any cause, whichever came first, assessed up to 13 months | 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 | Study days 1, 2 & 3 | 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. |
Countries
Canada
Contacts
CONTACTSunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services
PRINCIPAL_INVESTIGATORAngela Jerath, MD
Sunnybrook Health Sciences Centre
Outcome results
None listed