Respiratory Distress Syndrome, NewbornVISUALNCT04406142
Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method
A study testing VISUAL in people with Respiratory Distress Syndrome, Newborn, run by Carmel Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- VISUAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jul 2018to 28 Feb 2022
- 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 Up to 3 days
- 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
- - 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, Multicenter Trial, Assessing the Feasibility of the VISUAL Method (Video Surfactant Administration Laryngoscopy)
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.
Read the 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.
- 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
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- VISUAL
- Keywords
- respiratory distress syndrome, videolaryngoscopy, newborn infant, premature newborn infant, surfactant administration
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISUALDevice
thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| treatment feasibility | Experimental | feasibility, safety and effectiveness assessment Receives: Device: VISUAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures
Success for surfactant administration - yes / no
Measured: 1 year
Secondary outcomes (6)
Secondary outcome measures 1
Assessment of the infants' SPO2 %
Measured: 1 year
Secondary outcome measures 2
Heart rate during the procedure
Measured: 1 year
Secondary outcome measures 3
Respiratory rate (breaths per minute)
Measured: 1 year
Secondary outcome measures 4
number of attempts for vocal cords visualization (number)
Measured: 1 year
Secondary outcome measures 5
Duration of the procedure (seconds)
Measured: 1 year
Secondary outcome measures 6
Need for mechanical ventilaton witin 24 hours following procedure (yes-no)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start15 Jul 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dany Waisman, Carmel Medical Center
- Investigators
- Dan I Waisman, MD, Principal investigator, Department of Neonatology, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406142
- Sponsor's protocol ID
- CMC-17-0007-CTIL
- Acronym
- VISUAL
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. 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, Multicenter Trial, Assessing the Feasibility of the VISUAL Method (Video Surfactant Administration Laryngoscopy)
- ClinicalTrials.gov ID
- NCT04406142
- Acronym / sponsor ID
- VISUAL / CMC-17-0007-CTIL
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- respiratory distress syndrome, videolaryngoscopy, newborn infant, premature newborn infant, surfactant administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 May 2020 (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.
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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| treatment feasibility | Experimental | Device: VISUALfeasibility, safety and effectiveness assessment |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- - 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.
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 |
|---|---|---|
| VISUALthin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy | Device | treatment feasibility |
Primary outcome
Primary outcome measures
Time frame: 1 year
Success for surfactant administration - yes / no
6 secondary outcomes
Secondary outcome measures 1
Time frame: 1 year
Secondary outcome measures 2
Time frame: 1 year
Secondary outcome measures 3
Time frame: 1 year
Secondary outcome measures 4
Time frame: 1 year
Secondary outcome measures 5
Time frame: 1 year
Secondary outcome measures 6
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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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.
Dan I Waisman, MD principal investigator
Department of Neonatology, Carmel 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 VISUAL in people with Respiratory Distress Syndrome, Newborn, run by Carmel Medical Center 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 4 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: finished, as of the sponsor's last update on 15 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome measures (time frame: 1 year). 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 15 Mar 2022.