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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Newborn
• Interventions: Device: VISUAL

• Registration Number: NCT04406142
• Lead Sponsor: Carmel Medical Center

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

Study Timeline

• Study Start: 2018-07-15
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment feasibility	VISUAL	feasibility, safety and effectiveness assessment

Primary Outcome Measures

Name	Time	Method
Primary outcome measures	1 year	Success for surfactant administration - yes / no

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures 2	1 year	Heart rate during the procedure
Secondary outcome measures 4	1 year	number of attempts for vocal cords visualization (number)
Secondary outcome measures 1	1 year	Assessment of the infants' SPO2 %
Secondary outcome measures 6	1 year	Need for mechanical ventilaton witin 24 hours following procedure (yes-no)
Secondary outcome measures 5	1 year	Duration of the procedure (seconds)
Secondary outcome measures 3	1 year	Respiratory rate (breaths per minute)

Trial Locations

Locations (1)

Department of Neonatology, Carmel Medical Center; 🇮🇱 Haifa, Israel