Success of Laryngeal Mask Airway (LMA) Insertion During Continuous Chest Compressions in Neonatal Resuscitation: A Randomized Crossover Simulation Study

NCT07681960 | Completed

• 1 other identifier: KSUEK-2026-09
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the time required for laryngeal mask airway (LMA) insertion, first-attempt success rates, and airway sealing quality (air leak) during neonatal resuscitation with and without interrupting chest compressions. Standard resuscitation guidelines recommend pausing chest compressions for airway interventions due to the difficulty of inserting devices during physical movement. However, interrupting compressions drops coronary and cerebral perfusion. This study tests whether an LMA can be successfully inserted without pausing compressions in a high-fidelity simulation model. A total of 32 anesthesiologists participate in this randomized, crossover simulation study using a high-fidelity neonatal manikin. Participants perform two different scenarios in a randomly allocated order: Scenario A involves standard LMA insertion with interrupted chest compressions, and Scenario B involves LMA insertion during continuous, uninterrupted chest compressions. The primary objective is to determine if performing the procedure under continuous chest compressions affects the procedure time, clinical success, air leak volumes, or the perceived workload and stress of the practitioners.

Conditions

Neonatal Resuscitation; Airway Management; Asphyxia Neonatorum; Cardiopulmonary Resuscitation (CPR)

Outcome Measures

Primary Outcomes (1)

• LMA Insertion Time

  The time (in seconds) elapsed from the moment the participant picks up the LMA until the device is seated in the anatomical position and the first lung ventilation is achieved.

  Periprocedural

Secondary Outcomes (3)

• First-attempt insertion success rate

  Periprocedural

• Measured Air Leak Volume

  1 minute post-procedure

• Perceived Procedural Difficulty

  Immediate post-procedure

Study Arms (2)

Group 1 (Scenario A -> B)

EXPERIMENTAL

Participants perform traditional LMA insertion with interrupted chest compressions first (Scenario A), followed by a 10-minute washout period, and then perform LMA insertion under continuous chest compressions (Scenario B).

Device: Size 1 ProSeal™ LMA

Group 2 (Scenario B -> A)

EXPERIMENTAL

Participants perform LMA insertion under continuous chest compressions first (Scenario B), followed by a 10-minute washout period, and then perform traditional LMA insertion with interrupted chest compressions (Scenario A).

Device: Size 1 ProSeal™ LMA

Interventions

Size 1 ProSeal™ LMA DEVICE

Laryngeal Mask Airway used for neonatal ventilation simulation.

Group 1 (Scenario A -> B); Group 2 (Scenario B -> A)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a senior anesthesiology resident (completed 2nd year) or an attending anesthesiologist.
• Voluntary participation with signed informed consent.

You may not qualify if:

• Refusal to participate.
• Major physical disability that limits psychomotor tasks.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam University, Faculty of Medicine

Kahramanmaraş, Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: June 23, 2026
• Primary Completion: June 24, 2026
• Study Completion: June 24, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

TU (1)