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

Carmel Medical Center23 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

VISUALDEVICE

thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy

Eligibility

Sex: ALLMax age: 3 Days

Medical Language ↔ Plain English

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.

Locations (1)

Department of Neonatology, Carmel Medical Center

Haifa, Israel

Outcomes

Primary Outcomes

Primary outcome measures

Success for surfactant administration - yes / no

Time frame: 1 year

Secondary Outcomes

Secondary outcome measures 1

Assessment of the infants' SPO2 %

Time frame: 1 year

Secondary outcome measures 2

Heart rate during the procedure

Time frame: 1 year

Secondary outcome measures 3

Respiratory rate (breaths per minute)

Time frame: 1 year

Secondary outcome measures 4

number of attempts for vocal cords visualization (number)

Time frame: 1 year

Secondary outcome measures 5

Duration of the procedure (seconds)

Time frame: 1 year

Secondary outcome measures 6

Need for mechanical ventilaton witin 24 hours following procedure (yes-no)

Time frame: 1 year

Data from ClinicalTrials.gov

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