LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS: a Crossover Randomized Controlled Manikin Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399628
• Other study ID #: NEOUNIPD2(2022)
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: June 11, 2022

Study information

• Verified date: July 2022
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Description:

Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure).

The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction.

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 11, 2022
• Est. primary completion date: June 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Level III NICU consultants and residents will be eligible to participate in the study

Exclusion Criteria:

• Refusal to participate in the study.

Related Conditions & MeSH terms

• Birth Weight
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Surfactant administration with less invasive surfactant administration (LISA) marked tip catheter
Participants will be assigned to perform the procedure with LISA catheter with a marked tip
• Surfactant administration with less invasive surfactant administration (LISA) unmarked tip catheter
Participants will be assigned to perform the procedure with LISA catheter with an unmarked tip

Locations

Country	Name	City	State
Italy	Daniele Trevisanuto	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who will achieve the positioning of the device at the correct depth in the trachea	Number of participants who will achieve the positioning of the device at the correct depth in the trachea (as assessed by the external observer using a laryngoscope).	5 minutes
Secondary	Time for positioning the device in the trachea	The time of device positioning will be defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe to the catheter	5 minutes
Secondary	Number of attempts for positioning the device in the trachea	The total number of attempts for positioning the device in the trachea	5 minutes
Secondary	Participant opinion on using the device	Participant opinion on using the device which will be evaluated using a Likert scale (1 worse outcome to 5 best outcome)	10 minutes