Intensive Care Units, Pediatric Clinical Trial
— ABOVEOfficial title:
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial
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 1 year.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 18 Years |
Eligibility | 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) 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. Pregnancy or lactation 7. Suspected or evidence of high intracranial pressure (ICP) |
Country | Name | City | State |
---|---|---|---|
Canada | Children's Hospital - London Health Sciences Centre | London | Ontario |
Canada | The Hospital for Sick Children (SickKids) | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 28 days | |
Other | 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. | 28 days | |
Other | Anti-psychotic drug use | The administration of anti-psychotic drugs will be captured from baseline until day 28. | 28 days | |
Other | Sedative drug use | The administration of sedative drugs will be captured from baseline until day 28. | 28 days | |
Other | Blood collection to assess biological markers of delirium, inflammation and brain injury | Participants over >2 years old will be able to participate in an optional blood collection sub-study that will look at 60 markers of delirium, inflammation and brain injury. | Study days 1, 2 & 3 | |
Other | Feasibility of neurocognitive assessment | Proportion of participants who complete 12 month neurocognitive assessment | 1-year post enrollment | |
Other | Neurocognitive scores | Assessment of scores from age-appropriate neurocognitive tests completed at 12-months post enrollment | 1-year post enrollment | |
Other | In-hospital mortality | Participant survival status will be captured daily for 28 days and reported at hospital discharge | 1 year | |
Other | Ventilator-free days | The use of a ventilator will be captured from baseline until day 28. The number of days a participant does not require a ventilator will be computed. | 28 days | |
Other | ICU-free days | ICU discharge date will be captured and compared to admission date to determine number of days the participant was not in the ICU up to 28 days. | 28 days | |
Primary | Participant recruitment | Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years). | 2 years | |
Secondary | 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. | 28 days | |
Secondary | 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. | 3 years | |
Secondary | 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. | From date of consent until the date of resolution or date of death from any cause, whichever came first, assessed up to 13 months | |
Secondary | 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. | Study days 1, 2 & 3 |
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