Clinical trial NCT04406142: Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method
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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: respiratory distress syndrome
videolaryngoscopy
newborn infant
premature newborn infant
surfactant administration
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 23
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: TREATMENT

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

1. - Number of attempts until surfactant is administrated
2. - Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.
3. - Duration of the entire procedure, form laryngoscope insertion to surfactants administration.

4. Secondary Endpoints

1. - Need of invasive mechanical ventilation in the next 24 hours.
2. - Complications reports
3. - Subjective procedure scale of assessment
4. - Unexpected pitfalls reports
5. - Safety assessment of the procedure

Eligibility criteria: 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.

Primary outcomes:
measure: Primary outcome measures
timeFrame: 1 year
Secondary outcomes:
measure: Secondary outcome measures 1
timeFrame: 1 year
measure: Secondary outcome measures 2
timeFrame: 1 year
measure: Secondary outcome measures 3
timeFrame: 1 year
measure: Secondary outcome measures 4
timeFrame: 1 year
measure: Secondary outcome measures 5
timeFrame: 1 year
measure: Secondary outcome measures 6
timeFrame: 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Neonatology, Carmel Medical Center
Study officials:
affiliation: Department of Neonatology, Carmel Medical Center
name: Dan I Waisman, MD
role: PRINCIPAL_INVESTIGATOR
References: