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OpenTrials
Completed

NCT Number: NCT07681960

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaraş Sütçü İmam University, Faculty of Medicine

Kahramanmaraş, 46100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Size 1 ProSeal™ LMA

Device

Laryngeal Mask Airway used for neonatal ventilation simulation.

Primary outcomes

  1. LMA Insertion Time

    Time frame: Periprocedural

    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.

Secondary outcomes

  1. First-attempt insertion success rate

    Time frame: Periprocedural

    Percentage of participants succeeding on the first try

  2. Measured Air Leak Volume

    Time frame: 1 minute post-procedure

    Measured Air Leak Volume (L/min) during 1-minute ventilation.

  3. Perceived Procedural Difficulty

    Time frame: Immediate post-procedure

    Measured via Visual Analogue Scale - VAS, 0 to 10

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

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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