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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
surfactant administration via thin catheter using a specially adapted VNscope
surfactant administration via thin catheter using a specially adapted VNscope
Haemek medical centre
Afula, Israel
Number of attempts until surfactant is administrated
Number of intubation attempts- higher values represent a worse outcome
Time frame: 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
Time frame: 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
Time frame: maximal age 3 days.
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
Time frame: 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
Time frame: 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
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Time frame: maximal age 3 days.
Unexpected pitfalls reports
Physician assessment to evaluate eny pitfalls during the procedure
Time frame: 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
Time frame: maximal age 3 days.