Airway ManagementNCT06337006
Laryngeal Mask Airway Failure in Pediatric Patients
An observational study of Airway Management, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified… Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- Placement of the laryngeal mask airway
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 1 Jul 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children using a Laryngeal mask for airway control during surgery
Who may be able to join
- During surgery, the upper airway is planned to be supported with LMA by the Anesthesiologist.
- American Society of Anesthesiologists (ASA) physical status I or II
Who cannot join
- Surgery duration longer than 1 hour,
- Airway difficulty is expected,
- Restriction in opening the mouth,
- Airway malformation,
- Active upper respiratory tract infections,
- History of narrow airway,
- Hyperthyroidism, goiter, airway mass,
- Patients at risk of gastroesophageal reflux and aspiration of stomach contents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Laryngeal Mask Airway Failure in Pediatric Patients With Objective Criteria: a Pilot Study
There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs.
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data.
Read the detailed description
Optimal use of extraglottic airways, including the laryngeal mask (LMA), has not been fully defined using real-world data. Usage patterns and the reported incidence of failure and complications in different geographic regions vary greatly. In the adult population, an observational study involving more than 15,000 cases revealed a 1.1% incidence of laryngeal mask failure, defined as intubation after laryngeal mask removal, and 62% of patients experienced significant airway complications.
Similar data are scarce in children. Pediatric laryngeal mask studies report adverse event frequencies ranging from 0% to 10%. These data are limited by the focus on specific surgical procedures or the small sample size resulting in simple univariate or inadequate multivariate analyses. Additionally, although data on adverse events are presented, laryngeal mask failure requiring endotracheal intubation has been reported infrequently.
There are a significant number of studies identifying risk factors for misplacement of LMAs. However, there are no objective data to define misplacement of LMAs.
1-2 mL of lidocaine gel was applied evenly to the classic LMA (Intavent Direct, Maidenhead, UK) capsule. The appropriate size of the LMA device (size 1.5 for 5-10 kg and size 2 for 10-20 kg) was selected according to the manufacturer's recommendation. The LMA was placed by an experienced anesthesiologist, with the patient's head in a neutral position, with a fully deflated cuff, and the patient's mouth was opened, then held parallel to the chest, and the device was advanced along the hard palate. The cuff of the device was inflated with a sufficient amount of air according to the manufacturer's instructions. After LMA placement, patients were divided into two groups as successful (Group S) or unsuccessful (Group non-S) according to bilateral equal chest movement during inspiration, square wave capnography, absence of gastric insufflation, epigastrium auscultation and adequate tidal volume delivery. Another experienced anesthesiologist recorded the set (8 mL/kg) tidal volume (VT), expiratory tidal volume, airway peak pressure, SpO2, EtCO2 measurements in three respiratory cycles. Airway leak (ΔVT); It was calculated by subtracting expiratory VT from the adjusted VT. Airway leak, airway peak pressure, SpO2 and EtCO2 measurement were determined as possible objective predictors for LMA placement failure. Postoperative airway complications; It was determined and recorded as soft tissue trauma, laryngospasm, bronchospasm, and severe cough attack.
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data.
- Conditions
- Airway Management
- Being tested
- Placement of the laryngeal mask airway
- Keywords
- Laryngeal mask airway, pediatric, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of the laryngeal mask airwayProcedure or surgery
Evaluation of patients' chest movement with manual ventilation, airway leak level, airway pressures, fingertip O2 saturation percentage, and capnogram results will be recorded and the correlation between clinical observation and measured parameters will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Group S | The LMA was successfully placed after the first attempt. Receives: Procedure: Placement of the laryngeal mask airway | |
| Group non-S | The LMA was not placed successfully after the first attempt. Receives: Procedure: Placement of the laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the unsuccess of placement of the laryngeal mask airway
Identification of variables associated with unsuccessful LMA placement
Measured: 15 minute
Secondary outcomes (1)
The relationship between LMA placement failure and postoperative airway complications
Relationship between LMA placement failure with postoperative airway complications
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Sep 2023
- Primary completion25 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- OZGUR KOMURCU, 1, Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337006
- Sponsor's protocol ID
- SÜKAEK 2023/15/13
- Status last verified
- Jul 2024
- First submitted
- 21 Mar 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: non
Publications
Farbood A, Tayyebi G, Naderi-Boldaji V, Asmarian N. Comparison of the ease of insertion and complications of the classical method of laryngeal mask airway insertion with an alternative method. Saudi J Anaesth. 2023 Apr-Jun;17(2):182-186. doi: 10.4103/sja.sja_681_22. Epub 2023 Mar 10.
PubMed 37260649Hernandez MR, Klock PA Jr, Ovassapian A. Evolution of the extraglottic airway: a review of its history, applications, and practical tips for success. Anesth Analg. 2012 Feb;114(2):349-68. doi: 10.1213/ANE.0b013e31823b6748. Epub 2011 Dec 16.
PubMed 22178627Van Zundert AAJ, Gatt SP, Kumar CM, Van Zundert TCRV, Pandit JJ. 'Failed supraglottic airway': an algorithm for suboptimally placed supraglottic airway devices based on videolaryngoscopy. Br J Anaesth. 2017 May 1;118(5):645-649. doi: 10.1093/bja/aex093. No abstract available.
PubMed 28510747
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Laryngeal Mask Airway Failure in Pediatric Patients With Objective Criteria: a Pilot Study
- ClinicalTrials.gov ID
- NCT06337006
- Acronym / sponsor ID
- SÜKAEK 2023/15/13
- Conditions
- Airway Management
- Keywords
- Laryngeal mask airway, pediatric, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 29 Mar 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.
There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs.
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data.
Detailed description
Optimal use of extraglottic airways, including the laryngeal mask (LMA), has not been fully defined using real-world data. Usage patterns and the reported incidence of failure and complications in different geographic regions vary greatly. In the adult population, an observational study involving more than 15,000 cases revealed a 1.1% incidence of laryngeal mask failure, defined as intubation after laryngeal mask removal, and 62% of patients experienced significant airway complications.
Similar data are scarce in children. Pediatric laryngeal mask studies report adverse event frequencies ranging from 0% to 10%. These data are limited by the focus on specific surgical procedures or the small sample size resulting in simple univariate or inadequate multivariate analyses. Additionally, although data on adverse events are presented, laryngeal mask failure requiring endotracheal intubation has been reported infrequently.
There are a significant number of studies identifying risk factors for misplacement of LMAs. However, there are no objective data to define misplacement of LMAs.
1-2 mL of lidocaine gel was applied evenly to the classic LMA (Intavent Direct, Maidenhead, UK) capsule. The appropriate size of the LMA device (size 1.5 for 5-10 kg and size 2 for 10-20 kg) was selected according to the manufacturer's recommendation. The LMA was placed by an experienced anesthesiologist, with the patient's head in a neutral position, with a fully deflated cuff, and the patient's mouth was opened, then held parallel to the chest, and the device was advanced along the hard palate. The cuff of the device was inflated with a sufficient amount of air according to the manufacturer's instructions. After LMA placement, patients were divided into two groups as successful (Group S) or unsuccessful (Group non-S) according to bilateral equal chest movement during inspiration, square wave capnography, absence of gastric insufflation, epigastrium auscultation and adequate tidal volume delivery. Another experienced anesthesiologist recorded the set (8 mL/kg) tidal volume (VT), expiratory tidal volume, airway peak pressure, SpO2, EtCO2 measurements in three respiratory cycles. Airway leak (ΔVT); It was calculated by subtracting expiratory VT from the adjusted VT. Airway leak, airway peak pressure, SpO2 and EtCO2 measurement were determined as possible objective predictors for LMA placement failure. Postoperative airway complications; It was determined and recorded as soft tissue trauma, laryngospasm, bronchospasm, and severe cough attack.
The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Procedure: Placement of the laryngeal mask airwayThe LMA was successfully placed after the first attempt. |
| Group non-S | – | Procedure: Placement of the laryngeal mask airwayThe LMA was not placed successfully after the first attempt. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children using a Laryngeal mask for airway control during surgery
Key inclusion criteria (2 listed)
- During surgery, the upper airway is planned to be supported with LMA by the Anesthesiologist.
- American Society of Anesthesiologists (ASA) physical status I or II
Key exclusion criteria (8 listed)
- Surgery duration longer than 1 hour,
- Airway difficulty is expected,
- Restriction in opening the mouth,
- Airway malformation,
- Active upper respiratory tract infections,
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 |
|---|---|---|
| Placement of the laryngeal mask airwayEvaluation of patients' chest movement with manual ventilation, airway leak level, airway pressures, fingertip O2 saturation percentage, and capnogram results will be recorded and the correlation between clinical observation and measured parameters will be evaluated. | Procedure or surgery | Group S, Group non-S |
Primary outcome
Evaluation of the unsuccess of placement of the laryngeal mask airway
Time frame: 15 minute
Identification of variables associated with unsuccessful LMA placement
1 secondary outcome
The relationship between LMA placement failure and postoperative airway complications
Time frame: 2 hour
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 10 Jul 2024.
- Background: PubMed 37260649Farbood A, Tayyebi G, Naderi-Boldaji V, Asmarian N. Comparison of the ease of insertion and complications of the classical method of laryngeal mask airway insertion with an alternative method. Saudi J Anaesth. 2023 Apr-Jun;17(2):182-186. doi: 10.4103/sja.sja_681_22. Epub 2023 Mar 10.
- Background: PubMed 22178627Hernandez MR, Klock PA Jr, Ovassapian A. Evolution of the extraglottic airway: a review of its history, applications, and practical tips for success. Anesth Analg. 2012 Feb;114(2):349-68. doi: 10.1213/ANE.0b013e31823b6748. Epub 2011 Dec 16.
- Background: PubMed 28510747Van Zundert AAJ, Gatt SP, Kumar CM, Van Zundert TCRV, Pandit JJ. 'Failed supraglottic airway': an algorithm for suboptimally placed supraglottic airway devices based on videolaryngoscopy. Br J Anaesth. 2017 May 1;118(5):645-649. doi: 10.1093/bja/aex093. No abstract available.
- Individual participant dataSharing planned: No. non
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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.
OZGUR KOMURCU, 1 study director
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management, run by Samsun 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 8 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 10 Jul 2024. 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?
Evaluation of the unsuccess of placement of the laryngeal mask airway (time frame: 15 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06337006, which also lists 3 linked publications.
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 Jul 2024.