Trial · NCT05867472
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
NCT05867472, Phase 3, Recruiting, Sunnybrook Health Sciences Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents. Trials, record NCT05867472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05867472
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
- NCT number
- NCT05867472
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Conditions
- Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children
- Interventions
- Isoflurane Inhalant Product
- First posted
- 2023-05-22
- Last updated
- 2026-02-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participant recruitment | 2 years | Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Other | Feasibility of collecting delirium scores | 28 days | 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. |
| Other | Delirium-free Coma-free days | 28 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. |
| Other | Anti-psychotic drug use | 28 days | The administration of anti-psychotic drugs will be captured from baseline until day 28. |
| Other | Sedative drug use | 28 days | The administration of sedative drugs will be captured from baseline until day 28. |
| Other | Blood collection to assess biological markers of delirium, inflammation and brain injury | Study days 1, 2 & 3 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05867472
GET https://conductscience.org/api/trials/v1/NCT05867472/registered