NCT04406142

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
DEVICE	VISUAL	thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy

Timeline

• Start date: 2018-07-15
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2020-05-28
• Last updated: 2022-03-15

Locations

1 site across 1 country: Israel