Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope (VISUAL)

Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - a Prospective Study Assessing the Feasibility of the VISUAL (Video Surfactant Administration Laryngoscopy) Method

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 of Peak Medic Ltd, Netania, Israel.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Device: using specially adapted VNscope; Drug: surfactant administration

Detailed Description

A prospective study to assess the safety and efficacy of surfactant administration via thin catheter using a specially adapted VNscope, originally used for endotracheal intubation and adapted for the administration of surfactant without the placement of an endotracheal tube.

Once neonates present respiratory distress, the adapted scope will be used - clinical and outcome measures will be collected to asses the safety and efficacy of the use

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • Haemek medical centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. - Premature infants with gestational age 30-36 weeks.
2. - Diagnosis of respiratory distress syndrome
3. - Treatment with antenatal steroids.
4. - Spontaneously breathing with non-invasive positive pressure ventilation.
5. - 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: preterm infants; A prospective study to assess the safety and efficacy of surfactant administration via thin catheter using a specially adapted VNscope, originally used for endotracheal intubation and adapted for the administration of surfactant without the placement of an endotracheal tube. A feasibility study of 10 preterm infants 30-36 gestational age at birth, that requires surfactant administration for the indication of respiratory distress syndrome, and do not require immediate intubation

Device: using specially adapted VNscope; surfactant administration via thin catheter using a specially adapted VNscope; Other Names: VNScope VNS0-000; VNBlade VNB0-000/1; Drug: surfactant administration; surfactant administration via thin catheter using a specially adapted VNscope; Other Names: Curosurf - a porcine surfactant routinely used for RDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts until surfactant is administrated	Number of intubation attempts- higher values represent a worse outcome	maximal age 3 days.
Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.	Monitoring the baby during the procedure and assessment of the infants' stability: hypoxia (Oxygen saturation less than 60% for more than 5 sec), bradycardia (HR less than 60 for more than 5 sec), tachycardia (HR more than 220 for more than 5 sec) bradycardia below 100 bpm and tachycardia above 220 bpm indicate worse outcome	maximal age 3 days.
Duration of the entire procedure, form laryngoscope insertion to surfactants administration and Laryngoscope blade out of the mouth.	Time measurement of the procedure, sorter time indicate a better outcome	maximal age 3 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of invasive mechanical ventilation in the next 24 hours.	Failure of non-invasive approach and conversion to invasive ventilation to evaluate the efficiency of the procedure	maximal age 3 days.
complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage	Documentation of the complication related to the procedure according to the clinical signs and chest x-ray after the procedure	maximal age 3 days.
Subjective procedure scale of assessment.	Physician subjective assessment to evaluate the feasibility of the procedure- IRB- approved survey aims to assess user experiences with Video Surfactant Administration Laryngoscopy method in NICU. The survey contains five levels- a) Very satisfied b) Somewhat satisfied c) Neither satisfied nor dissatisfied d) Somewhat dissatisfied e) Very dissatisfied	maximal age 3 days.
Unexpected pitfalls reports	Physician assessment to evaluate eny pitfalls during the procedure	maximal age 3 days.
Safety assessment of the procedure (Physician questionnaire)	Physician questionnaire- Do you feel VISUAL method is safe for the premature baby? a)Yes b)Maybe c)No	maximal age 3 days.

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Collaborators: Carmel Medical Center
• Investigators: Principal Investigator: Gil talmon, dr, HaEmek Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (ACTUAL): February 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: video laryngoscope; minimally invasive surfactant administration
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: 0149-18-EMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No