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

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
VISUAL
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring respiratory distress syndrome, videolaryngoscopy, newborn infant, premature newborn infant, surfactant administration

Eligibility Criteria

undefined - 3 Days (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. - 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.

Sites / Locations

  • Department of Neonatology, Carmel Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment feasibility

Arm Description

feasibility, safety and effectiveness assessment

Outcomes

Primary Outcome Measures

Primary outcome measures
Success for surfactant administration - yes / no

Secondary Outcome Measures

Secondary outcome measures 1
Assessment of the infants' SPO2 %
Secondary outcome measures 2
Heart rate during the procedure
Secondary outcome measures 3
Respiratory rate (breaths per minute)
Secondary outcome measures 4
number of attempts for vocal cords visualization (number)
Secondary outcome measures 5
Duration of the procedure (seconds)
Secondary outcome measures 6
Need for mechanical ventilaton witin 24 hours following procedure (yes-no)

Full Information

First Posted
February 10, 2020
Last Updated
March 13, 2022
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04406142
Brief Title
Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method
Acronym
VISUAL
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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
Yes

5. Study Description

Brief Summary
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.
Detailed 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 - Number of attempts until surfactant is administrated - Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia. - Duration of the entire procedure, form laryngoscope insertion to surfactants administration. 4. Secondary Endpoints - Need of invasive mechanical ventilation in the next 24 hours. - Complications reports - Subjective procedure scale of assessment - Unexpected pitfalls reports - Safety assessment of the procedure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
respiratory distress syndrome, videolaryngoscopy, newborn infant, premature newborn infant, surfactant administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment feasibility
Arm Type
Experimental
Arm Description
feasibility, safety and effectiveness assessment
Intervention Type
Device
Intervention Name(s)
VISUAL
Intervention Description
thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy
Primary Outcome Measure Information:
Title
Primary outcome measures
Description
Success for surfactant administration - yes / no
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Secondary outcome measures 1
Description
Assessment of the infants' SPO2 %
Time Frame
1 year
Title
Secondary outcome measures 2
Description
Heart rate during the procedure
Time Frame
1 year
Title
Secondary outcome measures 3
Description
Respiratory rate (breaths per minute)
Time Frame
1 year
Title
Secondary outcome measures 4
Description
number of attempts for vocal cords visualization (number)
Time Frame
1 year
Title
Secondary outcome measures 5
Description
Duration of the procedure (seconds)
Time Frame
1 year
Title
Secondary outcome measures 6
Description
Need for mechanical ventilaton witin 24 hours following procedure (yes-no)
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Premature infants with gestational age 30-36 weeks. - Diagnosis of respiratory distress syndrome - 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
Dan I Waisman, MD
Organizational Affiliation
Department of Neonatology, Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology, Carmel Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

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

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