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

Primary Purpose

Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
using specially adapted VNscope
surfactant administration
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Respiratory Distress Syndrome focused on measuring video laryngoscope, minimally invasive surfactant administration

Eligibility Criteria

30 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haemek medical centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

preterm infants

Arm 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. 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

Outcomes

Primary Outcome Measures

Number of attempts until surfactant is administrated
Number of intubation attempts- higher values represent a worse outcome
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
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

Secondary Outcome Measures

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
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
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
Unexpected pitfalls reports
Physician assessment to evaluate eny pitfalls during the procedure
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

Full Information

First Posted
January 8, 2019
Last Updated
February 12, 2020
Sponsor
HaEmek Medical Center, Israel
Collaborators
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03846960
Brief Title
Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
Collaborators
Carmel Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
video laryngoscope, minimally invasive surfactant administration

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
intervention of a device product being evaluated in a small clinical trial to determine the feasibility of the product
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preterm infants
Arm Type
Experimental
Arm 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. 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
Intervention Type
Device
Intervention Name(s)
using specially adapted VNscope
Other Intervention Name(s)
VNScope VNS0-000; VNBlade VNB0-000/1
Intervention Description
surfactant administration via thin catheter using a specially adapted VNscope
Intervention Type
Drug
Intervention Name(s)
surfactant administration
Other Intervention Name(s)
Curosurf - a porcine surfactant routinely used for RDS
Intervention Description
surfactant administration via thin catheter using a specially adapted VNscope
Primary Outcome Measure Information:
Title
Number of attempts until surfactant is administrated
Description
Number of intubation attempts- higher values represent a worse outcome
Time Frame
maximal age 3 days.
Title
Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.
Description
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
Time Frame
maximal age 3 days.
Title
Duration of the entire procedure, form laryngoscope insertion to surfactants administration and Laryngoscope blade out of the mouth.
Description
Time measurement of the procedure, sorter time indicate a better outcome
Time Frame
maximal age 3 days.
Secondary Outcome Measure Information:
Title
Need of invasive mechanical ventilation in the next 24 hours.
Description
Failure of non-invasive approach and conversion to invasive ventilation to evaluate the efficiency of the procedure
Time Frame
maximal age 3 days.
Title
complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage
Description
Documentation of the complication related to the procedure according to the clinical signs and chest x-ray after the procedure
Time Frame
maximal age 3 days.
Title
Subjective procedure scale of assessment.
Description
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
Time Frame
maximal age 3 days.
Title
Unexpected pitfalls reports
Description
Physician assessment to evaluate eny pitfalls during the procedure
Time Frame
maximal age 3 days.
Title
Safety assessment of the procedure (Physician questionnaire)
Description
Physician questionnaire- Do you feel VISUAL method is safe for the premature baby? a)Yes b)Maybe c)No
Time Frame
maximal age 3 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Premature infants with gestational age 30-36 weeks. - Diagnosis of respiratory distress syndrome - Treatment with antenatal steroids. - Spontaneously breathing with non-invasive positive pressure ventilation. - maximal age 3 days. Exclusion Criteria: - Apgar score at 5 min < 5 - Need for chest compressions or medication upon delivery. - Evident major congenital malformation, metabolic or genetic disorders. - Clinical evidence of sepsis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil talmon, dr
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek medical centre
City
Afula
Country
Israel

12. IPD Sharing Statement

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Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope

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