Paediatric AirwayLMAUSPEDNCT06712732
Ultrasound Evaluation of Laryngeal Mask Airway (LMA) Placement in Pediatric Patients and Its Relationship to Postoperative Complications
An observational study of Paediatric Airway, run by University Of Perugia.
Trial summary
This study was designed to improve understanding of some respiratory reactions that can occur after surgery, such as difficulty breathing or persistent cough. These events, technically called PRAE (postoperative respiratory complications), are common reactions in children who have undergone surgery, and our aim is to… Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Paediatric Airway
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients undergoing surgery under general anesthesia with laryngeal mask airway placement.
Who may be able to join
- Patients undergoing surgery under general anesthesia with laryngeal mask airway placement.
Who cannot join
- Patients without the need for invasive airway management or undergoing surgery requiring orotracheal intubation.
- Patients with known craniofacial malformations.
- Patients undergoing neck surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Valutazione Ultrasonografica Del Corretto Posizionamento Della Maschera Laringea Nel Paziente Pediatrico
This study was designed to improve understanding of some respiratory reactions that can occur after surgery, such as difficulty breathing or persistent cough. These events, technically called PRAE (postoperative respiratory complications), are common reactions in children who have undergone surgery, and our aim is to find out if there are signs that can help us predict them, reducing their incidence in the future.
During surgery, the child will receive general anesthesia, which will put him or her to sleep and not feel pain. In this context, a laryngeal mask airway (LMA) will be used to help the child breathe. The laryngeal mask airway is a soft device that is placed in the throat and allows the airway to be kept open, making breathing possible. This is a standard tool that will be used during surgery regardless of participation in the study.
Read more
The aim of this study is to better understand the relationship between the correct positioning of the laryngeal mask airway, measured by a specific ultrasound score, and the frequency of postoperative respiratory events in pediatric patients. As previously stated, these complications are common and well known in pediatric anesthesia practice, and the study aims to explore whether adequate ultrasound assessment can help predict and prevent them in the future. The study aims to observe the position of the laryngeal mask airway through a simple ultrasound and verify whether there is a relationship between the way the mask is positioned and the possibility of postoperative respiratory events. This type of ultrasound is non-invasive and does not add risk to the child.
This ultrasound check will take place without affecting the normal treatment of the patient and does not involve any additional risk or discomfort.
The study is purely observational: this means that we will collect information without modifying in any way the care already foreseen for the child.
The laryngeal mask airway and neck ultrasound are already part of standard medical practice, and the study does not present any additional risks. In this case, it is only a matter of reporting in all children who will participate in the study the "results" of ecological story of the neck (which we will process according to a score) and to evaluate whether there is a relationship between this score and the occurrence of respiratory adverse events upon awakening.
The overall duration of the study is 24 months. In total, we expect to include about 340 patients.
- Conditions
- Paediatric Airway
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation between PRAE incidence and correlation with ultrasound score
The aim of this observational study is to evaluate whether there is a correlation between ultrasonographic data and the incidence of postoperative complications in pediatric patients undergoing general anesthesia for surgery, in order to evaluate the possible predictive power on complications of this diagnostic technique. Postoperative complications or PRAE (Perioperative Respiratory Adverse Events) are: major complications (bronchospasm and laryngospasm) and minor complications (desaturation <95%, signs of airway obstruction with increased effort of accessory respiratory muscles and/or snoring, severe cough for more than 10s continuously, postoperative stridor, presence of blood traces at removal of the LMA)
Measured: From enrollment to the discharge from the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study startMar 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric AirwayStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachele Simonte, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712732
- Sponsor's protocol ID
- LMAUSPED
- Acronym
- LMAUSPED
- Status last verified
- Feb 2025
- First submitted
- 26 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Ultrasonografica Del Corretto Posizionamento Della Maschera Laringea Nel Paziente Pediatrico
- ClinicalTrials.gov ID
- NCT06712732
- Acronym / sponsor ID
- LMAUSPED / LMAUSPED
- Conditions
- Paediatric Airway
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Dec 2024 (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.
This study was designed to improve understanding of some respiratory reactions that can occur after surgery, such as difficulty breathing or persistent cough. These events, technically called PRAE (postoperative respiratory complications), are common reactions in children who have undergone surgery, and our aim is to find out if there are signs that can help us predict them, reducing their incidence in the future.
During surgery, the child will receive general anesthesia, which will put him or her to sleep and not feel pain. In this context, a laryngeal mask airway (LMA) will be used to help the child breathe. The laryngeal mask airway is a soft device that is placed in the throat and allows the airway to be kept open, making breathing possible. This is a standard tool that will be used during surgery regardless of participation in the study.
The aim of this study is to better understand the relationship between the correct positioning of the laryngeal mask airway, measured by a specific ultrasound score, and the frequency of postoperative respiratory events in pediatric patients. As previously stated, these complications are common and well known in pediatric anesthesia practice, and the study aims to explore whether adequate ultrasound assessment can help predict and prevent them in the future. The study aims to observe the position of the laryngeal mask airway through a simple ultrasound and verify whether there is a relationship between the way the mask is positioned and the possibility of postoperative respiratory events. This type of ultrasound is non-invasive and does not add risk to the child.
This ultrasound check will take place without affecting the normal treatment of the patient and does not involve any additional risk or discomfort.
The study is purely observational: this means that we will collect information without modifying in any way the care already foreseen for the child.
The laryngeal mask airway and neck ultrasound are already part of standard medical practice, and the study does not present any additional risks. In this case, it is only a matter of reporting in all children who will participate in the study the "results" of ecological story of the neck (which we will process according to a score) and to evaluate whether there is a relationship between this score and the occurrence of respiratory adverse events upon awakening.
The overall duration of the study is 24 months. In total, we expect to include about 340 patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing surgery under general anesthesia with laryngeal mask airway placement.
Key inclusion criteria (1 listed)
- Patients undergoing surgery under general anesthesia with laryngeal mask airway placement.
Key exclusion criteria (3 listed)
- Patients without the need for invasive airway management or undergoing surgery requiring orotracheal intubation.
- Patients with known craniofacial malformations.
- Patients undergoing neck surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation between PRAE incidence and correlation with ultrasound score
Time frame: From enrollment to the discharge from the recovery room
The aim of this observational study is to evaluate whether there is a correlation between ultrasonographic data and the incidence of postoperative complications in pediatric patients undergoing general anesthesia for surgery, in order to evaluate the possible predictive power on complications of this diagnostic technique. Postoperative complications or PRAE (Perioperative Respiratory Adverse Events) are: major complications (bronchospasm and laryngospasm) and minor complications (desaturation <95%, signs of airway obstruction with increased effort of accessory respiratory muscles and/or snoring, severe cough for more than 10s continuously, postoperative stridor, presence of blood traces at removal of the LMA)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Airway, run by University Of Perugia.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachele Simonte (+39 075578 2420, rachele.simonte@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation between PRAE incidence and correlation with ultrasound score (time frame: From enrollment to the discharge from the recovery room). 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 10 Feb 2025.