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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled sedation - volatile anesthetic | Experimental | The ICU patient will receive Isoflurane. Dosage will be modified as per health care team guidance for the best treatment of the participant. |
|
| IV sedation - standard of care | No Intervention | The ICU patient will receive standard of care, which is IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoflurane Inhalant Product | Drug | Isoflurane will be administered using an inhalation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant recruitment | Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Attrition |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Delirium-free Coma-free days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services | Contact | 416-480-6100 | ABOVETrial@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Angela Jerath, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Children's Hospital | Recruiting | Hamilton | Ontario | L8N 3Z5 | Canada |
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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).
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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.
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 |
| 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 |
| 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 |
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 |
| Anti-psychotic drug use | The administration of anti-psychotic drugs will be captured from baseline until day 28. | 28 days |
| Sedative drug use | The administration of sedative drugs will be captured from baseline until day 28. | 28 days |
| 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 |
| Feasibility of neurocognitive assessment | Proportion of participants who complete 12 month neurocognitive assessment | 1-year post enrollment |
| Neurocognitive scores | Assessment of scores from age-appropriate neurocognitive tests completed at 12-months post enrollment | 1-year post enrollment |
| In-hospital mortality | Participant survival status will be captured daily for 28 days and reported at hospital discharge | 1 year |
| 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 |
| 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 |
| Children's Hospital - London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
|
| The Hospital for Sick Children (SickKids) | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
|
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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