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Completed

NCT Number: NCT04406142

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

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.

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Key information

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neonatology, Carmel Medical Center

Haifa, Israel

About this study

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

  • - Number of attempts until surfactant is administrated
  • - Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.
  • - Duration of the entire procedure, form laryngoscope insertion to surfactants administration.
  • Secondary Endpoints
  • - Need of invasive mechanical ventilation in the next 24 hours.
  • - Complications reports
  • - Subjective procedure scale of assessment
  • - Unexpected pitfalls reports
  • - Safety assessment of the procedure

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VISUAL

Device

thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy

Primary outcomes

  1. Primary outcome measures

    Time frame: 1 year

    Success for surfactant administration - yes / no

Secondary outcomes

  1. Secondary outcome measures 1

    Time frame: 1 year

    Assessment of the infants' SPO2 %

  2. Secondary outcome measures 2

    Time frame: 1 year

    Heart rate during the procedure

  3. Secondary outcome measures 3

    Time frame: 1 year

    Respiratory rate (breaths per minute)

  4. Secondary outcome measures 4

    Time frame: 1 year

    number of attempts for vocal cords visualization (number)

  5. Secondary outcome measures 5

    Time frame: 1 year

    Duration of the procedure (seconds)

  6. Secondary outcome measures 6

    Time frame: 1 year

    Need for mechanical ventilaton witin 24 hours following procedure (yes-no)

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study title

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)

Acronym: VISUAL

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 28, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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