Clinical trial NCT03846960: Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: video laryngoscope
minimally invasive surfactant administration
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: Carmel Medical Center
First posted: 2019-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: intervention of a device product being evaluated in a small clinical trial to determine the feasibility of the product
Primary purpose: DEVICE_FEASIBILITY

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.

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

Eligibility 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.

Primary outcomes:
measure: Number of attempts until surfactant is administrated
timeFrame: maximal age 3 days.
measure: Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.
timeFrame: maximal age 3 days.
measure: Duration of the entire procedure, form laryngoscope insertion to surfactants administration and Laryngoscope blade out of the mouth.
timeFrame: maximal age 3 days.
Secondary outcomes:
measure: Need of invasive mechanical ventilation in the next 24 hours.
timeFrame: maximal age 3 days.
measure: complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage
timeFrame: maximal age 3 days.
measure: Subjective procedure scale of assessment.
timeFrame: maximal age 3 days.
measure: Unexpected pitfalls reports
timeFrame: maximal age 3 days.
measure: Safety assessment of the procedure (Physician questionnaire)
timeFrame: maximal age 3 days.
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical centre
Study officials:
affiliation: haemek medical center
name: Gil talmon, dr
role: PRINCIPAL_INVESTIGATOR
References: