Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope

Respiratory Distress Syndrome Clinical Trial

— VISUAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03846960
• Other study ID #: 0149-18-EMC
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• using specially adapted VNscope
surfactant administration via thin catheter using a specially adapted VNscope

Drug:
• surfactant administration
surfactant administration via thin catheter using a specially adapted VNscope

Locations

Country	Name	City	State
Israel	Haemek medical centre	Afula

Sponsors (2)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel	Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of attempts until surfactant is administrated	Number of intubation attempts- higher values represent a worse outcome	maximal age 3 days.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	Unexpected pitfalls reports	Physician assessment to evaluate eny pitfalls during the procedure	maximal age 3 days.
Secondary	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.