Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method
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- STATUS
- Recruiting
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- participants needed
- 100
-
- sponsor
- Carmel Medical Center
Summary
Surfactant administration via thin catheter using a specially adapted video laryngoscope - a prospective, multicenter trial, assessing the feasibility of the VISUAL method (Video Surfactant Administration Laryngoscopy).
The study will search for the number of attempts until surfactant is administrated, assessment of the infants' stability during the procedure, duration of the entire procedure, form laryngoscope insertion to surfactant administration.
Description
In this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.).
The laryngoscope is manufactured by Peak Medic Ltd, Natania, Israel.
Primary Endpoints
- - Number of attempts until surfactant is administrated
- - Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.
- - Duration of the entire procedure, form laryngoscope insertion to surfactants administration.
- Secondary Endpoints
- - Need of invasive mechanical ventilation in the next 24 hours.
- - Complications reports
- - Subjective procedure scale of assessment
- - Unexpected pitfalls reports
- - Safety assessment of the procedure
Details
| Condition | respiratory distress syndrome of newborn |
|---|---|
| Age | 1years or below |
| Treatment | VISUAL |
| Clinical Study Identifier | NCT04406142 |
| Sponsor | Carmel Medical Center |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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