Trial · NCT05609877
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LISA failure within 24 hours. | 24 hours after procedure. | The primary outcome will be LISA failure in terms of the need for endotracheal intubation and mechanical ventilation for at least 30 minutes (cumulated) within 24 hours after the procedure. |
| Secondary | Incidence of additional fentanyl administration | During the procedure, an average of 5-10 minutes. | This will include the number of injection(s), dosage, cumulated dose, and indications defined as pain/discomfort/sedation/other. |
| Secondary | Pain or discomfort during the procedure (according to COMFORTneo score >14). | 24 hours after procedure | This will include a numerical and a categorical variable (COMFORTneo score \>/\< 14). |
| Secondary | Bradycardia <100 BPM for a minimum duration of 4 seconds. | 24 hours after procedure. | This is a categorical variable (yes/no). |
| Secondary | Need for a second dose of surfactant | 24 hours after procedure. | This is a categorical variable (yes/no). |
| Secondary | Escalation from LISA to INSURE in the same attempt | 24 hours after procedure. | This is a categorical variable (yes/no). |
| Secondary | Apnoea that require bag and mask ventilation during the procedure | 24 hours after procedure. | This is a categorical variable (yes/no). |
| Secondary | Observed surfactant reflux | 24 hours after procedure. | This is a categorical variable (yes/no). |
| Secondary | Desaturation with SaO2 (right extremity measure) <85% during the procedure | 24 hours after procedure. | This is a categorical variable (yes/no). |
| Secondary | Procedural time consumption from the introduction of the laryngoscope blade into the oral cavity to removal of the catheter. | 24 hours after procedure. | This is a categorical variable (yes/no). |
| Secondary | Number of attempts of insertion of the catheter in the trachea. | 24 hours after procedure. | This is a numerical variable. |
| Secondary | Number of attempts of insertion of the laryngoscope in the oral cavity. | 24 hours after procedure. | This is a numerical variable. |
| Secondary | Time from meeting the criteria for surfactant treatment until surfactant administration | 24 hours after procedure. | This is a numerical variable in minutes. |
| Secondary | Incidence of endotracheal intubation. | 48 hours after procedure | This is a categorical variable. |
| Secondary | Incidence of pneumothorax within 48 hours after LISA. | 48 hours after procedure. | This is a categorical variable. |
| Secondary | Incidence of massive pulmonary haemorrhage within 48 hours after LISA (defined as the aspiration of haemorrhagic secretions from the trachea concurrent with the need for escalated respiratory support). | 48 hours after procedure. | This is a categorical variable. |
| Secondary | Incidence of in-hospital mortality before discharge. | Through study completion, an average of 6 months. | This is a categorical variable. |
| Secondary | Cumulated duration of mechanical ventilation during hospitalisation. | Before discharge (through study completion, an average of 6 months). | This is a numerical variable. |
| Secondary | Cumulated duration of positive pressure ventilation during hospitalisation. | Before discharge (through study completion, an average of 6 months). | This is a numerical variable. |
| Secondary | Incidence of escalation of respiratory support from CPAP to other NIV modes during hospitalisation. | Before discharge (through study completion, an average of 6 months). | This is a categorical variable. |
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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