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

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatology
• Intervention / Treatment: Procedure: Intubation with stylet

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All premature infants born at less than 30 weeks gestation between 2016 and 2022 in the General Faculty Hospital in Prague were eligible for evaluation.

Description

Inclusion Criteria:

• intubation in the delivery room

Exclusion Criteria:

• both method used, video record not available

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With stylet group; Intubation performed with stylet.	Procedure: Intubation with stylet; The cohort of premature infants was intubated with stylet.
Without stylet group; Intubation performed without stylet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Intubation; Resuscitation; Stylet; Extremely premature infant
• Other Study ID Numbers: 118/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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