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

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)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Device: VISUAL

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Department of Neonatology, Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment feasibility; feasibility, safety and effectiveness assessment	Device: VISUAL; thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome measures	Success for surfactant administration - yes / no	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Dan I Waisman, MD, Department of Neonatology, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: respiratory distress syndrome; videolaryngoscopy; newborn infant; premature newborn infant; surfactant administration
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: CMC-17-0007-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No