Neonatal ResuscitationNCT07681960
Success of Laryngeal Mask Airway (LMA) Insertion During Continuous Chest Compressions in Neonatal Resuscitation: A Randomized Crossover Simulation Study
A study testing Size 1 ProSeal™ LMA in people with Neonatal Resuscitation and Airway Management, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Resuscitation, Airway Management, Asphyxia Neonatorum
- What is being tested?
- Size 1 ProSeal™ LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2026to 24 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a senior anesthesiology resident (completed 2nd year) or an attending anesthesiologist.
- Voluntary participation with signed informed consent.
Who cannot join
- Refusal to participate.
- Major physical disability that limits psychomotor tasks.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University, Faculty of Medicine
Kahramanmaraş, Kahramanmaraş, 46100
About this 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.
- Conditions
- Neonatal Resuscitation, Airway Management, Asphyxia Neonatorum, Cardiopulmonary Resuscitation (CPR)
- Being tested
- Size 1 ProSeal™ LMA
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Size 1 ProSeal™ LMADevice
Laryngeal Mask Airway used for neonatal ventilation simulation.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Size 1 ProSeal™ LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
Secondary outcomes (3)
First-attempt insertion success rate
Percentage of participants succeeding on the first try
Measured: Periprocedural
Measured Air Leak Volume
Measured Air Leak Volume (L/min) during 1-minute ventilation.
Measured: 1 minute post-procedure
Perceived Procedural Difficulty
Measured via Visual Analogue Scale - VAS, 0 to 10
Measured: Immediate post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start23 Jun 2026
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengizhan Yavuz, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681960
- Sponsor's protocol ID
- KSUEK-2026-09
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Laryngeal Mask Airway (LMA) Insertion During Continuous Chest Compressions in Neonatal Resuscitation: A Randomized Crossover Simulation Study
- ClinicalTrials.gov ID
- NCT07681960
- Acronym / sponsor ID
- KSUEK-2026-09
- Conditions
- Neonatal Resuscitation, Airway Management, Asphyxia Neonatorum, Cardiopulmonary Resuscitation (CPR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Scenario A -> B) | Experimental | Device: Size 1 ProSeal™ LMAParticipants 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). |
| Group 2 (Scenario B -> A) | Experimental | Device: Size 1 ProSeal™ LMAParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a senior anesthesiology resident (completed 2nd year) or an attending anesthesiologist.
- Voluntary participation with signed informed consent.
Key exclusion criteria (2 listed)
- Refusal to participate.
- Major physical disability that limits psychomotor tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Size 1 ProSeal™ LMALaryngeal Mask Airway used for neonatal ventilation simulation. | Device | Group 1 (Scenario A -> B), Group 2 (Scenario B -> A) |
Primary outcome
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.
3 secondary outcomes
First-attempt insertion success rate
Time frame: Periprocedural
Measured Air Leak Volume
Time frame: 1 minute post-procedure
Perceived Procedural Difficulty
Time frame: Immediate post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Size 1 ProSeal™ LMA in people with Neonatal Resuscitation and Airway Management, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LMA Insertion Time (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.