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OpenTrials
Completed

NCT Number: NCT06316765

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • intubation in the delivery room

Exclusion criteria

  • both method used, video record not available

Treatment and study plan

Intubation with stylet

Procedure

The cohort of premature infants was intubated with stylet.

Primary outcomes

  1. The primary outcome was defined as successful initial intubation attempt.

    Time frame: immediately after procedure

    Successful placement of the endotracheal tube on the first intubation attempt, followed by an increase in heart rate and blood oxygen saturation.

Secondary outcomes

  1. Secondary outcomes was defined as the duration of intubation courses until successful placement of the endotracheal tube.

    Time frame: immediately after procedure

    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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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