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

Respiratory Distress Syndrome, Newborn Clinical Trial

— VISUAL  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406142
• Other study ID #: CMC-17-0007-CTIL
• Status: Completed
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• VISUAL
thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy

Locations

Country	Name	City	State
Israel	Department of Neonatology, Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measures	Success for surfactant administration - yes / no	1 year
Secondary	Secondary outcome measures 1	Assessment of the infants' SPO2 %	1 year
Secondary	Secondary outcome measures 2	Heart rate during the procedure	1 year
Secondary	Secondary outcome measures 3	Respiratory rate (breaths per minute)	1 year
Secondary	Secondary outcome measures 4	number of attempts for vocal cords visualization (number)	1 year
Secondary	Secondary outcome measures 5	Duration of the procedure (seconds)	1 year
Secondary	Secondary outcome measures 6	Need for mechanical ventilaton witin 24 hours following procedure (yes-no)	1 year