Trial · NCT04016246
Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.
NCT04016246, Phase 3, Completed, University Hospital, Grenoble
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation. Trials, record NCT04016246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04016246
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.
- NCT number
- NCT04016246
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 233 participants, actual
- Lead sponsor
- University Hospital, Grenoble
- Conditions
- Respiratory Distress Syndrome in Premature Infant
- Interventions
- Propofol-Lipuro, Placebos
- First posted
- 2019-07-11
- Last updated
- 2026-06-09
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | need for mechanical ventilation after the procedure | 72hours | Rate of mechanical ventilation from the start of the LISA procedure up to 72 hours of life Pain before procedure (need of ketamine administration) or within 1 hour following first injection of propofol/placebo (FANS score ≥ 6) |
| Secondary | Rate of MV (mechanical ventilation ) in each class of GA (<28, 28-31wGA) | 72hours | Rate of MV (mechanical ventilation ) from the start of the LISA procedure up to 72 hours of life in each class of GA (\<28, 28-31wGA) |
| Secondary | FANS during LISA and 1h after LISA | 1hour | Faceless acute neonatal pain scale (FANS) assessed during LISA and 1 hour after the procedure by an independent operator. |
| Secondary | number of ketamine administrations for rescue | before LISA Procedure | Number of ketamine administrations for rescue in order to obtain a FANS score \<6 and to be able to proceed to LISA. |
| Secondary | Number of laryngoscopies | during LISA Procedure (T0) | Number of laryngoscopies needed to perform LISA |
| Secondary | Tolerance and efficacy (Per procedure events): Apnea | during LISA Procedure (T0) | Apnea requiring bag mask ventilation |
| Secondary | Tolerance and efficacy (Per procedure events): emergency intubation | from drug injection to 1hour after | Emergency intubation after the drug injection before the LISA procedure can be performed or within 1h following the drug injection |
| Secondary | Tolerance and efficacy (Per procedure events): Viby Mogensen score | during LISA Procedure | Clinician's satisfaction during laryngoscopy with the Viby Mogensen score : Item Score 1 Score 2 Score 3 Score 4 Laryngoscopy Easy Fair Difficult Impossible Vocal cords Open Moving Closing Closed Coughing None Slight Moderate Severe Jaw relaxation Complete Slight Stiff Rigid Limb movements None Slight Moderate Severe the total score is calculated adding each item scores. min score = 5. max score = 20. An easy intubation would obtain a low score and a difficult intubation would have a high score. |
| Secondary | BPD (bronchopulmonary dysplasia) at 36 weeks of Gestational Age | equivalent to 36 weeks of Gestational Age | Broncho Pulmonary Dysplasia at 36 weeks of Gestational Age |
| Secondary | In-hospital morbidity and mortality: pneumothorax | 72hours post LISA Procedure | Pneumothorax within 72hours |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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.
Papers13
The papers the trial lists on ClinicalTrials.gov.
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/NCT04016246
GET https://conductscience.org/api/trials/v1/NCT04016246/registered?page=2