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Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method — VISUAL  

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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 1. - Number of attempts until surfactant is administrated 2. - Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia. 3. - Duration of the entire procedure, form laryngoscope insertion to surfactants administration. 4. Secondary Endpoints 1. - Need of invasive mechanical ventilation in the next 24 hours. 2. - Complications reports 3. - Subjective procedure scale of assessment 4. - Unexpected pitfalls reports 5. - Safety assessment of the procedure ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04406142
Study type Interventional
Source Carmel Medical Center
Contact
Status Completed
Phase N/A
Start date July 15, 2018
Completion date February 28, 2022
View Details
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