Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2022-02-28

Brief Summary

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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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Detailed Description

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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

Conditions

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Respiratory Distress Syndrome, Newborn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment feasibility

feasibility, safety and effectiveness assessment

Group Type EXPERIMENTAL

VISUAL

Intervention Type DEVICE

thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy

Interventions

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VISUAL

thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. \- Premature infants with gestational age 30-36 weeks.
2. \- Diagnosis of respiratory distress syndrome
3. \- Spontaneously breathing with non-invasive positive pressure ventilation.
4. \- Maximal age 3 days.

Exclusion Criteria

1. \- Apgar score at 5 min \< 5
2. \- Need for chest compressions or medication upon delivery.
3. \- Evident major congenital malformation, metabolic or genetic disorders.
4. \- Clinical evidence of sepsis.

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No