A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants

Neonatology Clinical Trial

Official title:

A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants < 30 Weeks.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06316765
• Other study ID #: 118/10
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. The goal is to compare the safety and efficiency of intubations with or without a stylet.

Description:

Recent studies have found that using a stylet does not offer any benefits during intubation across a diverse infant population. The research, however, specifically targets extremely and very premature infants undergoing elective or rescue intubation in the delivery room. A single-center retrospective observational study was conducted to compare the number of intubation attempts, the duration of intubation until successful, and the rate of associated desaturations exceeding 20%. The outcomes were determined through video recordings and statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• intubation in the delivery room

Exclusion Criteria:

• both method used, video record not available

Related Conditions & MeSH terms

• Neonatology

Intervention

Procedure:
• Intubation with stylet
The cohort of premature infants was intubated with stylet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was defined as successful initial intubation attempt.	Successful placement of the endotracheal tube on the first intubation attempt, followed by an increase in heart rate and blood oxygen saturation.	immediately after procedure
Secondary	Secondary outcomes was defined as the duration of intubation courses until successful placement of the endotracheal tube.	The duration from the first insertion of the laryngoscope blade to the successful placement of the endotracheal tube, followed by an increase in heart rate and blood oxygen saturation, measured in seconds.	immediately after procedure