Trial · NCT04383730
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of days off the ventilator (VFD28, for ventilator-free days), taking into account death as a competing event | Day 28 after inclusion | Ventilator-free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after intubation, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. A period of assisted breathing lasting less than 24 hours and for the purpose of a surgical procedure will not count against the VFD calculation. If a patient was receiving assisted breathing at day 27 or died prior to day 28, VFDs will be zero. Patients transferred to another hospital or other health care facility will be followed to day 28 to assess this endpoint. |
| Secondary | All-cause mortality | Days 7, 14, and 28 after inclusion | All-cause mortality |
| Secondary | Ventilator-free days | Days 7 and 14 after inclusion | Ventilator-free days to days 7 and 14 are defined as the number of days from the time of initiating unassisted breathing to day 7 and 14 after intubation, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to days 7 and 14 If a patient returns to assisted breathing and subsequently achieves unassisted breathing to days 7 and 14 , VFDs will be counted from the end of the last period of assisted breathing to days 7 and 14. A period of assisted breathing lasting less than 24 hours and for the purpose of a surgical procedure will not count against the VFD calculation. If a patient was receiving assisted breathing at day 6 or 13 or died prior to days 7 and 14, respectively,VFDs to days 7 and 14 will be zero. Patients transferred to another hospital or other health care facility will be followed to days 7 and 14 to assess this endpoint. |
| Secondary | ICU-free days | Day 28 after inclusion | Number of days alive and not in the ICU from inclusion to day 28 |
| Secondary | Duration of invasive mechanical ventilation | Day 28 after inclusion | Total duration of controlled mechanical ventilation to day 28 |
| Secondary | Duration of controlled mechanical ventilation | Day 28 after inclusion | Total duration of controlled mechanical ventilation to day 28 |
| Secondary | Physiological measures of lung function | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion | Arterial hypoxemia, as assessed by the partial pressure of arterial oxygen-to-fraction of inspired oxygen ratio (PaO2/FiO2) |
| Secondary | Physiological measures of lung function | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion | Partial pressure of arterial carbon dioxide (PaCO2) |
| Secondary | Physiological measures of lung function | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion | Inspiratory plateau pressure |
| Secondary | Physiological measures of lung function | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion | Driving pressure |
| Secondary | Physiological measures of lung function | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion | Mode of mechanical ventilation (assisted versus controlled) |
| Secondary | Physiological measures of lung function | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion | If available, 100 ms occlusion pressure (P0.1), a marker of respiratory drive |
| Secondary | Development of complications | Day 7 from inclusion | Development of pneumothorax |
| Secondary | Development of complications | Day 7 from inclusion | Supraventricular tachycardia |
| Secondary | Development of complications | Day 7 from inclusion | New onset atrial fibrillation |
| Secondary | Duration of vasopressor use | Day 28 after inclusion | Total duration (in days) of vasopressor use |
| Secondary | Duration of renal replacement therapy | Day 28 after inclusion | Total duration (in days)of renal replacement therapy |
| Secondary | Duration (in days) of any adjuvant therapies | Day 7 from inclusion | Adjuvant therapies are defined as: prone position, recruitment maneuvers, inhaled nitric oxide, inhaled epoprostenol sodium, high frequency ventilation, ECMO, neuromuscular blockade |
| Secondary | Duration of continuous neuromuscular blockade | Day 28 from inclusion | Number of days with continuous neuromuscular blockade |
| Secondary | Type of sedation practices | Day 28 from inclusion | Sedation drug(s) used (name(s)) |
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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