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Trial · NCT06203405

Registered outcomes29

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

ListOutcomeTime frameDescription
PrimarySuccessful extubation within 14 days after randomization14 days after randomizationSuccessful extubation within 14 days without reintubation within 28 days after ICU admission
SecondarySuccessful extubation within 7 days after randomization7 days after randomizationSuccessful extubation within 7 days without reintubation within 28 days after ICU admission
SecondarySuccessful extubation within 28 days after randomization28 days after randomizationSuccessful extubation without reintubation within 28 days after ICU admission
SecondaryDuration of mechanical ventilationFrom date of intubation until the date of last successful extubation or date of death from any cause, whichever came first, assessed up to 28 daysTime from intubation to the last successful extubation
SecondaryVentilator-free days to day 28 after randomization28 days after randomizationNumber of days alive without mechanical ventilation
SecondaryReintubation rate at 7 days after randomization7 days after randomizationNumber of reintubation within 7 days after randomization
SecondarySelf extubation rate at 7 days after extubation7 days after randomizationNumber of self extubation (accidentally extubation without physician's order) within 7 days after randomization
SecondaryPost-extubation respiratory failureFrom date of randomization until the date of the first event of post-extubation respiratory failure or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 days
Patients who meet at least one of the following criteria within 72 hours after extubation: respiratory rate more than 35 breaths/minute, oxygen saturation less than 90% or PaO2 less than 80 mmHg despite receiving FiO2 \>50%, respiratory acidosis with pH \<7.35 or PaCO2 \>50 mmHg or increase of 20% from baseline.
SecondaryTracheostomyFrom date of randomization until the date of tracheostomy or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 daysNumber of tracheostomy performed
SecondaryLung injury score on day 3 after randomization3 days after randomizationLung injury score on day 3 after randomization
SecondaryLung injury score on day 7 after randomization7 days after randomizationLung injury score on day 7 after randomization
SecondaryPaO2/FiO2 ratio on day 3 after randomization3 days after randomizationPaO2/FiO2 ratio on day 3 after randomization
SecondaryPaO2/FiO2 ratio on day 7 after randomization7 days after randomizationPaO2/FiO2 ratio on day 7 after randomization
SecondaryRates of new diagnosis of ARDS according to the new Berlin criteria after randomizationFrom date of randomization until the date of new onset ARDS diagnosis after randomization or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 daysNumber of ARDS diagnoses after randomization
SecondaryDelirium during ICU admissionFrom date of randomization until the date of diagnosis of delirium diagnosis or date of death from any cause or ICU discharge, whichever came first, assessed up to 28 daysDelirium assessed by positive CAM-ICU criteria during ICU admission
SecondaryGlasgow Outcome Scale (GOS) at hospital dischargeFrom date of randomization until the date of hospital discharge or date of death from any cause , whichever came first, assessed up to 28 days
Functional status assessed by Glasgow Outcome Scale (GOS) at hospital discharge * Unabbreviated title: Glasgow Outcome Scale * Maximum score: 5 = good recovery * 4 = Moderate disability, 3 = Severe disability, 2 = Vegetative state * Minimum score: 1 = death (Higher scores mean better outcome)
SecondaryICU all-cause mortalityFrom date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 28 daysAll-cause mortality during ICU admission
SecondaryHospital all-cause mortalityFrom date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 daysAll-cause mortality during hospital admission
Secondary28-day mortality after randomization28 days after randomizationAll-cause mortality during 28-day after randomization
SecondaryICU length of stayFrom date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 28 daysTime from ICU admission to ICU discharge

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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