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

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ClinicalTrials.gov Identifier: NCT03846960
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Carmel Medical Center
Information provided by (Responsible Party):
Gil Talmon, HaEmek Medical Center, Israel

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Device: using specially adapted VNscope Drug: surfactant administration Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Device Feasibility
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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


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 Name: VNScope VNS0-000; VNBlade VNB0-000/1

Drug: surfactant administration
surfactant administration via thin catheter using a specially adapted VNscope
Other Name: Curosurf - a porcine surfactant routinely used for RDS




Primary Outcome Measures :
  1. Number of attempts until surfactant is administrated [ Time Frame: maximal age 3 days. ]
    Number of intubation attempts- higher values represent a worse outcome

  2. Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia. [ Time Frame: maximal age 3 days. ]

    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


  3. Duration of the entire procedure, form laryngoscope insertion to surfactants administration and Laryngoscope blade out of the mouth. [ Time Frame: maximal age 3 days. ]
    Time measurement of the procedure, sorter time indicate a better outcome


Secondary Outcome Measures :
  1. Need of invasive mechanical ventilation in the next 24 hours. [ Time Frame: maximal age 3 days. ]
    Failure of non-invasive approach and conversion to invasive ventilation to evaluate the efficiency of the procedure

  2. complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage [ Time Frame: maximal age 3 days. ]
    Documentation of the complication related to the procedure according to the clinical signs and chest x-ray after the procedure

  3. Subjective procedure scale of assessment. [ Time Frame: maximal age 3 days. ]
    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

  4. Unexpected pitfalls reports [ Time Frame: maximal age 3 days. ]
    Physician assessment to evaluate eny pitfalls during the procedure

  5. Safety assessment of the procedure (Physician questionnaire) [ Time Frame: maximal age 3 days. ]

    Physician questionnaire- Do you feel VISUAL method is safe for the premature baby?

    a)Yes b)Maybe c)No




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Ages Eligible for Study:   30 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846960


Contacts
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Contact: Gil Talmon, Dr 00972523731342 talmon_gi@clalit.org.il
Contact: Gil Talmon, Dr 0097246494321 talmon_gi@clalit.org.il

Sponsors and Collaborators
HaEmek Medical Center, Israel
Carmel Medical Center
Investigators
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Principal Investigator: Gil talmon, dr haemek medical center

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Responsible Party: Gil Talmon, Senior Attending Neonatologist, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03846960     History of Changes
Other Study ID Numbers: 0149-18-EMC
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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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
Keywords provided by Gil Talmon, HaEmek Medical Center, Israel:
video laryngoscope
minimally invasive surfactant administration
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents