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

Israel Healthcare Foundation

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Device: VISUAL

Study type: Interventional

Funder types: Other

Identifiers

NCT04406142

CMC-17-0007-CTIL

Details and patient eligibility

About

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.

Full 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

5. • Need of invasive mechanical ventilation in the next 24 hours.
6. • Complications reports
7. • Subjective procedure scale of assessment
8. • Unexpected pitfalls reports
9. • Safety assessment of the procedure

Enrollment: 23 patients

Sex: All

Ages: Under 3 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. • Premature infants with gestational age 30-36 weeks.
2. • Diagnosis of respiratory distress syndrome
3. • Spontaneously breathing with non-invasive positive pressure ventilation.
4. • Maximal age 3 days.

Exclusion criteria

1. • Apgar score at 5 min < 5
2. • Need for chest compressions or medication upon delivery.
3. • Evident major congenital malformation, metabolic or genetic disorders.
4. • Clinical evidence of sepsis.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

treatment feasibility

Experimental group

Description:

feasibility, safety and effectiveness assessment

Treatment:

Device: VISUAL