Trial · NCT04383730
Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)
NCT04383730, Completed, University Hospital, Clermont-Ferrand
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19). Trials, record NCT04383730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04383730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)
- NCT number
- NCT04383730
- Status
- Completed
- Enrollment
- 203 participants, actual
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Conditions
- Critically Illness, Sedation, Invasive Mechanical Ventilation, Acute Respiratory Distress Syndrome
- Interventions
- Intravenous sedation, Inhaled sedation
- First posted
- 2020-05-12
- Last updated
- 2021-09-05
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33857185 | DERIVED |
Source PubMed
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/NCT04383730
GET https://conductscience.org/api/trials/v1/NCT04383730/registered?page=2