Respiratory Distress SyndromeVISUALNCT03846960
Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope
A study testing using specially adapted VNscope and surfactant administration in people with Respiratory Distress Syndrome, run by HaEmek Medical Center, Israel at 1 site in Israel.
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.). Read more about this study
- Who is it for?
- Ages 30 to 36 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- using specially adapted VNscope and surfactant administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Respiratory Distress Syndrome
- Being tested
- using specially adapted VNscope, surfactant administration
- Keywords
- video laryngoscope, minimally invasive surfactant administration
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using specially adapted VNscopeDevice
Also called VNScope VNS0-000; VNBlade VNB0-000/1
surfactant administration via thin catheter using a specially adapted VNscope
surfactant administrationDrug
Also called Curosurf - a porcine surfactant routinely used for RDS
surfactant administration via thin catheter using a specially adapted VNscope
| Study group | Role | What they receive |
|---|---|---|
| preterm infants | Experimental | 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 Receives: Device: using specially adapted VNscope; Drug: surfactant administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts until surfactant is administrated
Number of intubation attempts- higher values represent a worse outcome
Measured: 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
Measured: 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
Measured: maximal age 3 days.
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: maximal age 3 days.
Unexpected pitfalls reports
Physician assessment to evaluate eny pitfalls during the procedure
Measured: 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
Measured: maximal age 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Nov 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Carmel Medical Center
- Responsible party
- Principal investigator, Gil Talmon, HaEmek Medical Center, Israel
- Investigators
- Gil talmon, dr, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846960
- Sponsor's protocol ID
- 0149-18-EMC
- Acronym
- VISUAL
- Status last verified
- Feb 2020
- First submitted
- 8 Jan 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03846960
- Acronym / sponsor ID
- VISUAL / 0149-18-EMC
- Conditions
- Respiratory Distress Syndrome
- Keywords
- video laryngoscope, minimally invasive surfactant administration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Carmel Medical Center
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intervention of a device product being evaluated in a small clinical trial to determine the feasibility of the product
| Arm | Type | Receives |
|---|---|---|
| preterm infants | Experimental | Device: using specially adapted VNscope, Drug: surfactant administrationA 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 |
Who may qualify
- Ages
- 30 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- - 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.
Key exclusion criteria (4 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| using specially adapted VNscopeAlso: VNScope VNS0-000; VNBlade VNB0-000/1surfactant administration via thin catheter using a specially adapted VNscope | Device | preterm infants |
| surfactant administrationAlso: Curosurf - a porcine surfactant routinely used for RDSsurfactant administration via thin catheter using a specially adapted VNscope | Drug | preterm infants |
Primary outcome
Number of attempts until surfactant is administrated
Time frame: maximal age 3 days.
Number of intubation attempts- higher values represent a worse outcome
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
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
5 secondary outcomes
Need of invasive mechanical ventilation in the next 24 hours.
Time frame: maximal age 3 days.
complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage
Time frame: maximal age 3 days.
Subjective procedure scale of assessment.
Time frame: maximal age 3 days.
Unexpected pitfalls reports
Time frame: maximal age 3 days.
Safety assessment of the procedure (Physician questionnaire)
Time frame: maximal age 3 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil talmon, dr principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using specially adapted VNscope and surfactant administration in people with Respiratory Distress Syndrome, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attempts until surfactant is administrated (time frame: maximal age 3 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.