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Trial · NCT06767358

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryFeasibility: Recruitment Rate3 months
Feasibility will be judged by the 3 outcomes of recruitment rate, consent rate, and protocol adherence. We define a successful recruitment rate of 0.5 patients per centre per month over the duration of the trial.
PrimaryFeasibility: Consent Rate3 monthsThis will be judged by the 3 outcomes of recruitment rate, consent rate, and protocol adherence. We will define \>75% consent rate as successful.
PrimaryFeasibility: Protocol Adherence3 monthsThis will be judged by the 3 outcomes of recruitment rate, consent rate, and protocol adherence. We will define ≥75% protocol adherence as successful.
SecondaryVentilator-free Days at 28 days28 Days
Secondary28-day mortality28 Days
SecondaryICU Mortality3 months
SecondaryICU Length of Stay3 months
SecondaryNumber of Participants receiving a Tracheostomy3 months
SecondaryHospital Mortality3 months
SecondaryHospital Length of Stay3 months
SecondaryDelirium28 Days
Delirium will be reported using the validated Confusion Assessment Method for the ICU (CAM-ICU) score (dichotomous score) or the Intensive Care Delirium Screening Checlist (ICDSC). Minimum Value: No Delirium Maximum Value: Delirium
SecondaryDelirium-Free/Coma-Free Days at 14 days14 days
SecondaryUse of anti-psychotics (total dosage)28 Days
SecondaryUse of benzodiazepines (total dosage)28 Days
SecondaryPost-traumatic stress disorder symptoms at 3 months post ICU discharge3 monthsThis outcome will use the validated Impact of Event Scale - Revised Minimum Value: 0 Maximum Value: 88 Value ≥ 33 consistent with PTSD
SecondaryTotal dosage of continuous sedative requirements over ICU stay28 DaysThis outcome will report the total dosage and weight-based mean dosage of continuous sedatives used in the ICU
SecondaryTotal dosage of analgesic requirements over ICU stay28 DaysThis outcome will report the total dosage and weight-based mean dosage of analgesics used in the ICU
SecondaryNumber of participants with arrhythmias28 DaysInclusive of atrial flutter/fibrillation, ventricular fibrillation, ventricular tachycardia
SecondaryNumber of times participants have emesis/vomiting28 DaysReported incidents of vomiting.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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