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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Distress Syndrome, Newborn
- Sponsor
- Carmel Medical Center
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Primary outcome measures
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Dany Waisman
Director of the Newborn Unit Department of Neonatology
Carmel Medical Center
Eligibility Criteria
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
Primary outcome measures
Time Frame: 1 year
Success for surfactant administration - yes / no
Secondary Outcomes
- Secondary outcome measures 1(1 year)
- Secondary outcome measures 2(1 year)
- Secondary outcome measures 4(1 year)
- Secondary outcome measures 6(1 year)
- Secondary outcome measures 5(1 year)
- Secondary outcome measures 3(1 year)