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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of attempts until surfactant is administrated
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 30 Weeks to 36 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
preterm infants
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
Intervention: using specially adapted VNscope (Device)
preterm infants
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
Intervention: surfactant administration (Drug)
Outcomes
Primary Outcomes
Number of attempts until surfactant is administrated
Time Frame: maximal age 3 days.
Number of intubation attempts- higher values represent a 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
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
Secondary Outcomes
- Unexpected pitfalls reports(maximal age 3 days.)
- Need of invasive mechanical ventilation in the next 24 hours.(maximal age 3 days.)
- Subjective procedure scale of assessment.(maximal age 3 days.)
- complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage(maximal age 3 days.)
- Safety assessment of the procedure (Physician questionnaire)(maximal age 3 days.)
Investigators
Gil Talmon
Senior Attending Neonatologist
HaEmek Medical Center, Israel