Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Carmel Medical Center
Updated on 19 February 2024
respiratory distress
prematurity
intermittent positive pressure ventilation
premature birth
pulmonary surfactant
laryngoscopy

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.

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
  5. - Need of invasive mechanical ventilation in the next 24 hours.
  6. - Complications reports
  7. - Subjective procedure scale of assessment
  8. - Unexpected pitfalls reports
  9. - Safety assessment of the procedure

Details
Condition respiratory distress syndrome of newborn
Age 1years or below
Treatment VISUAL
Clinical Study IdentifierNCT04406142
SponsorCarmel Medical Center
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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