- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07681960
Success of Laryngeal Mask Airway (LMA) Insertion During Continuous Chest Compressions in Neonatal Resuscitation: A Randomized Crossover Simulation Study
July 1, 2026 updated by: Cengizhan Yavuz, Kahramanmaras Sutcu Imam University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kahramanmaraş
-
Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 46100
- Kahramanmaraş Sütçü İmam University, Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 (Scenario A -> B)
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).
|
Laryngeal Mask Airway used for neonatal ventilation simulation.
|
|
Experimental: Group 2 (Scenario B -> A)
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).
|
Laryngeal Mask Airway used for neonatal ventilation simulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-attempt insertion success rate
Time Frame: Periprocedural
|
Percentage of participants succeeding on the first try
|
Periprocedural
|
|
Measured Air Leak Volume
Time Frame: 1 minute post-procedure
|
Measured Air Leak Volume (L/min) during 1-minute ventilation.
|
1 minute post-procedure
|
|
Perceived Procedural Difficulty
Time Frame: Immediate post-procedure
|
Measured via Visual Analogue Scale - VAS, 0 to 10
|
Immediate post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2026
Primary Completion (Actual)
June 24, 2026
Study Completion (Actual)
June 24, 2026
Study Registration Dates
First Submitted
June 26, 2026
First Submitted That Met QC Criteria
July 1, 2026
First Posted (Actual)
July 2, 2026
Study Record Updates
Last Update Posted (Actual)
July 2, 2026
Last Update Submitted That Met QC Criteria
July 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSUEK-2026-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Airway Management
-
Bursa City HospitalEmre ULUSOYNot yet recruitingAirway Management | Difficult AirwayTurkey (Türkiye)
-
Royal Hospital, OmanNot yet recruitingDifficult Airway | Obesity Difficult Airway Airway Management
-
Kutahya Health Sciences UniversityCompletedAirway Management | Difficult Airway | Difficult Airway IntubationTurkey (Türkiye)
-
NHS TaysideTerminated
-
Akdeniz University HospitalCompletedAirway Management | Difficult Airway | Obstetric AnesthesiaTurkey (Türkiye)
-
Kocaeli City HospitalActive, not recruitingAirway Management | Airway Complication of AnaesthesiaTurkey
-
Mongi Slim HospitalCompletedAirway Management | Upper Airway Sonographic EvaluationTunisia
-
Diskapi Teaching and Research HospitalNot yet recruitingAirway ManagementTurkey (Türkiye)
-
Thomas RivaThe Hospital for Sick Children; Children's Hospital of Philadelphia; Charite... and other collaboratorsRecruitingAirway ManagementUnited States, Australia, Switzerland, Italy, Canada, Germany, Brazil
-
Peking Union Medical College HospitalNot yet recruiting
Clinical Trials on Size 1 ProSeal™ LMA
-
Seoul National University Bundang HospitalCompletedOropharyngeal InjuryKorea, Republic of
-
National University of MalaysiaUnknownEvaluation of Optimal Operating Table Height for Successful Placement of Proseal Laryngeal Mask AirwayMalaysia
-
Prince of Songkla UniversityUnknownInadequate or Impaired Breathing Pattern or VentilationThailand
-
Medical University InnsbruckCompleted
-
University of MalayaCompletedA Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kgLaryngeal Mask AirwayMalaysia
-
Medical University InnsbruckCompletedVentilation | Difficult AirwayAustria
-
Dr.Mahak MehtaCompletedProseal LMA vs Air-Q LMA vs Ambu AurGain LMA
-
National Taiwan University HospitalCompletedthe Influence of Oropharyngeal Leak Pressure and Sealing Between the Mask and Vocal Cord During Changing Patient's Head and Neck PositionTaiwan
-
Inonu UniversityCompletedAirway Complication of AnaesthesiaTurkey
-
Medical University InnsbruckCompleted