Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial

Intubation; Difficult or Failed Clinical Trial

Official title:

Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06263790
• Other study ID #: NEOUNIPD1(2024)
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: University Hospital Padova
• Contact: Daniele Trevisanuto
• Phone: 3406632734
• Email: daniele.trevisanuto[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.

This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.

Description:

Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Furthermore, the procedure times are often longer than recommended by international guidelines, and repeated intubation attempts are associated with adverse events in unstable neonates.

Objectives: To compare success and time of intubation through intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.

Methods: This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure was the intubation success rate at the first attempt. Secondary outcome measures were the total time needed for the endotracheal tube positioning (calculated as the sum of the time of device positioning in all attempts), and the participant's opinion on using the device (evaluated using a Likert scale).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Intubation; Difficult or Failed
• Neonatal Disease

Intervention

Device:
• Intubating laryngeal mask
Intubation through a laryngeal mask
• Direct laryngoscopy
Intubation by using a direct laryngoscope

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

References & Publications (5)

Gerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth. 2010 Jun;57(6):588-601. doi: 10.1007/s12630-010-9272-x. Epub 2010 Jan 29. — View Citation

Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41. doi: 10.1016/j.jpeds.2005.01.029. — View Citation

Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24. — View Citation

Sauer CW, Kong JY, Vaucher YE, Finer N, Proudfoot JA, Boutin MA, Leone TA. Intubation Attempts Increase the Risk for Severe Intraventricular Hemorrhage in Preterm Infants-A Retrospective Cohort Study. J Pediatr. 2016 Oct;177:108-113. doi: 10.1016/j.jpeds.2016.06.051. Epub 2016 Jul 26. — View Citation

Sawyer T, Foglia E, Hatch LD, Moussa A, Ades A, Johnston L, Nishisaki A. Improving neonatal intubation safety: A journey of a thousand miles. J Neonatal Perinatal Med. 2017;10(2):125-131. doi: 10.3233/NPM-171686. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success at the first attempt	The success of the first attempt will be defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer.	3 minutes after the initiation of the procedure
Secondary	Time of device positioning	Time of device positioning will be calculated as the sum of the time of device positioning in all attempts, as the procedure will be repeated in case of incorrect positioning	3 minutes after the initiation of the procedure
Secondary	Participant's opinion on difficulty of the procedure	Participants will report their opinion on insertion difficulty and overall difficulty using a Likert scale (1= not difficult, 5=very difficult)	5 minutes after end of the procedure