Airway ManagementSNIFFLMANCT05035264
Head Position for Laryngeal Mask Air Leak and Performance in Paediatric Patients (Neutral, Sniffing and Beyond Sniffing Position)
A study testing Laryngeal mask insertion in people with Airway Management, run by Brno University Hospital at 1 site in Czechia.
Trial summary
The correct head position for airway management is considered as a mainstay of good clinical practice. The recommended head position for all patients is the horizontal position of the head with in tragus-to- sternal notch in line alignment. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Airway Management
- What is being tested?
- Laryngeal mask insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2022to 31 Dec 2025
- 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 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 2-19 years
- Informed consent
- Elective airway management
- laryngeal mask for airway management
Who cannot join
- Outside the age limits
- Decline to participate
- Predicted or confirmed difficult airway
- Cervical spine injury
- limited access to head of the patient after anaesthesia induction (for the measuement purposes)
- Intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Head Position for Laryngeal Mask Air Leak and Performance in Paediatric Patients (Neutral, Sniffing and Beyond Sniffing Position): Prospective Randomized Trial
The correct head position for airway management is considered as a mainstay of good clinical practice. The recommended head position for all patients is the horizontal position of the head with in tragus-to- sternal notch in line alignment. This could be achieved in infant (under two years) supporting the shoulder, neutral head positioning in children between 2-8 (12) years and with so called "sniffing position" (SP) in patients over 12 year by supporting the head (i.e. with pillow) to reach the proper alignment (tragus to sternal notch). Although, this could be considered as gold standard, there are currently insufficient high quality evidence-based data to confirm the association between the better laryngeal view during the direct laryngoscopy and tragus-to-sternal notch position. Recently, "beyond sniffing" position was described as further head elevation (compared to sniffing position) in adult patients. Beyond sniffing position was associated with superior laryngeal inlet visualization compared to standard sniffing position in common elective adult airway management (patients with suspected or confirmed difficult airway was excluded). The hypothesis of SNIFF LM trial is that the sniffing position or even beyond sniffing position could be associated with superior laryngeal mask performance (lower incidence of air leak, LM easier introduction) compared neutral position in paediatric patients undergoing elective paediatric anaesthesia
Read the detailed description
Paediatric patients (between 2-18 years) undergoing elective airway management without predicted/confirmed difficult airway will be eligible for inclusion. The patients will be screened for eligibility during the preanaesthesia visit in anaesthesiology examination room. After informed consent the patients will be randomized into 3 groups (according to the induction head position) - neutral head position (without head elevation, head supported with the hollow foam circle to prevent side head movement), sniffing position (head support with inflatable pillow the reach the horizontal in-line alignment of tragus-to-sternal notch line) and beyond sniffing position (further 25% increase of head support compared to sniffing position). The randomization will be performed by the Institute of Biostatistics and Analysis in form of sealed envelopes. The group allocation will be 1:1:1. After fulfilling the inclusion criteria and obtaining the informed consent the patient will be randomized into 3 groups. Before anaesthesia induction the head of the patient will be positioned into the predefined position according to the results of randomization. The anaesthesia induction could be performer either inhalation or intravenous route. After anaesthesia induction, the laryngeal mask will be inserted in the selected position. After laryngeal mask insertion, stabilisation of vital signs and of anaesthesia depth, the measurement will be intiated within 5 minutes. After one minute of ventilation 3 leak volumes (inspiration - expiration tidal volume) together with the peak airway pressure (3 measurements) will be recorded (the mean volume and mean pressure will be analyzed). Patient´s head will be repositioned into the 2nd position and after one minute of ventilation leak volume and airway pressure will be recorded as previously described, after measurement, the head position will be repositioned into the 3rd positon and the measurement will be repeated. The incidence of 1st insertion attempt failure rate, incidence of laryngeal mask failure rate, incidence of the need for reposition will be recorded together with the incidence of airway related complications.
- Conditions
- Airway Management
- Being tested
- Laryngeal mask insertion
- Keywords
- Supraglottic Airway Devices, Laryngeal mask airway, Head position, Paediatric patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask insertionDevice
Laryngeal mask insertion in neutral position
Laryngeal mask insertionDevice
Laryngeal mask insertion in sniffing position
Laryngeal mask insertionDevice
Laryngeal mask insertion in beyond sniffing position
| Study group | Role | What they receive |
|---|---|---|
| Neutral head position | Active comparator | Laryngeal mask will be inserted after anaesthesia induction in neutral head position Receives: Device: Laryngeal mask insertion |
| Sniffing position | Active comparator | Laryngeal mask will be inserted after anaesthesia induction in sniffing head position Receives: Device: Laryngeal mask insertion |
| Beyond sniffing position | Experimental | Laryngeal mask will be inserted after anaesthesia induction in sniffing head position Receives: Device: Laryngeal mask insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
leak volume in 3 different head position in every patient (1st position will be randomized)
leak volume in 3 different head position in every patient (1st position will be randomized) defined by the average leak obtained from 3 measurements in selected position
Measured: 1 minute mechanical ventilation in predefined head position
Secondary outcomes (5)
Leak pressure in 3 different head position in every patient (1st position will be randomized)
Leak pressure in 3 different head position in every patient (1st position will be randomized) defined by the first audible leak during stepwise increasing inspiratory pressure
Measured: 1 minute mechanical ventilation in predefined head position
incidence of failed 1st attempt insertion rate
incidence of failed 1st attempt insertion rate
Measured: anaesthesia induction
incidence of overall laryngeal mask failure
incidence of overall laryngeal mask failure
Measured: anaesthesia induction
incidence of the need for head reposition to obtain better airway seal in the 3 randomized head positions.
incidence of the need for head reposition to obtain better airway seal in the 3 randomized head positions
Measured: Intraoperatively
Incidence of airway related complication
Incidence of airway related complication -regurgitation/aspiration, desaturation, oesophageal intubation, laryngeal/airway injury incidence
Measured: From anaesthesia induction until dismission from postanaesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Paediatric patients (between 2-18 years) undergoing elective airway management without predicted/confirmed difficult airway with the laryngeal mask airway after anaesthesia induction
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035264
- Sponsor's protocol ID
- KDAR SNIFF LMA
- Acronym
- SNIFFLMA
- Status last verified
- May 2026
- First submitted
- 30 Aug 2021
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Position for Laryngeal Mask Air Leak and Performance in Paediatric Patients (Neutral, Sniffing and Beyond Sniffing Position): Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05035264
- Acronym / sponsor ID
- SNIFFLMA / KDAR SNIFF LMA
- Conditions
- Airway Management
- Keywords
- Supraglottic Airway Devices, Laryngeal mask airway, Head position, Paediatric patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Sep 2021 (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 correct head position for airway management is considered as a mainstay of good clinical practice. The recommended head position for all patients is the horizontal position of the head with in tragus-to- sternal notch in line alignment. This could be achieved in infant (under two years) supporting the shoulder, neutral head positioning in children between 2-8 (12) years and with so called "sniffing position" (SP) in patients over 12 year by supporting the head (i.e. with pillow) to reach the proper alignment (tragus to sternal notch). Although, this could be considered as gold standard, there are currently insufficient high quality evidence-based data to confirm the association between the better laryngeal view during the direct laryngoscopy and tragus-to-sternal notch position. Recently, "beyond sniffing" position was described as further head elevation (compared to sniffing position) in adult patients. Beyond sniffing position was associated with superior laryngeal inlet visualization compared to standard sniffing position in common elective adult airway management (patients with suspected or confirmed difficult airway was excluded). The hypothesis of SNIFF LM trial is that the sniffing position or even beyond sniffing position could be associated with superior laryngeal mask performance (lower incidence of air leak, LM easier introduction) compared neutral position in paediatric patients undergoing elective paediatric anaesthesia
Detailed description
Paediatric patients (between 2-18 years) undergoing elective airway management without predicted/confirmed difficult airway will be eligible for inclusion. The patients will be screened for eligibility during the preanaesthesia visit in anaesthesiology examination room. After informed consent the patients will be randomized into 3 groups (according to the induction head position) - neutral head position (without head elevation, head supported with the hollow foam circle to prevent side head movement), sniffing position (head support with inflatable pillow the reach the horizontal in-line alignment of tragus-to-sternal notch line) and beyond sniffing position (further 25% increase of head support compared to sniffing position). The randomization will be performed by the Institute of Biostatistics and Analysis in form of sealed envelopes. The group allocation will be 1:1:1. After fulfilling the inclusion criteria and obtaining the informed consent the patient will be randomized into 3 groups. Before anaesthesia induction the head of the patient will be positioned into the predefined position according to the results of randomization. The anaesthesia induction could be performer either inhalation or intravenous route. After anaesthesia induction, the laryngeal mask will be inserted in the selected position. After laryngeal mask insertion, stabilisation of vital signs and of anaesthesia depth, the measurement will be intiated within 5 minutes. After one minute of ventilation 3 leak volumes (inspiration - expiration tidal volume) together with the peak airway pressure (3 measurements) will be recorded (the mean volume and mean pressure will be analyzed). Patient´s head will be repositioned into the 2nd position and after one minute of ventilation leak volume and airway pressure will be recorded as previously described, after measurement, the head position will be repositioned into the 3rd positon and the measurement will be repeated. The incidence of 1st insertion attempt failure rate, incidence of laryngeal mask failure rate, incidence of the need for reposition will be recorded together with the incidence of airway related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Paediatric patients (between 2-18 years) undergoing elective airway management without predicted/confirmed difficult airway with the laryngeal mask airway after anaesthesia induction
| Arm | Type | Receives |
|---|---|---|
| Neutral head position | Active comparator | Device: Laryngeal mask insertionLaryngeal mask will be inserted after anaesthesia induction in neutral head position |
| Sniffing position | Active comparator | Device: Laryngeal mask insertionLaryngeal mask will be inserted after anaesthesia induction in sniffing head position |
| Beyond sniffing position | Experimental | Device: Laryngeal mask insertionLaryngeal mask will be inserted after anaesthesia induction in sniffing head position |
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 2-19 years
- Informed consent
- Elective airway management
- laryngeal mask for airway management
Key exclusion criteria (6 listed)
- Outside the age limits
- Decline to participate
- Predicted or confirmed difficult airway
- Cervical spine injury
- limited access to head of the patient after anaesthesia induction (for the measuement purposes)
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 |
|---|---|---|
| Laryngeal mask insertionLaryngeal mask insertion in neutral position | Device | Beyond sniffing position, Neutral head position, Sniffing position |
| Laryngeal mask insertionLaryngeal mask insertion in sniffing position | Device | Beyond sniffing position, Neutral head position, Sniffing position |
| Laryngeal mask insertionLaryngeal mask insertion in beyond sniffing position | Device | Beyond sniffing position, Neutral head position, Sniffing position |
Primary outcome
leak volume in 3 different head position in every patient (1st position will be randomized)
Time frame: 1 minute mechanical ventilation in predefined head position
leak volume in 3 different head position in every patient (1st position will be randomized) defined by the average leak obtained from 3 measurements in selected position
5 secondary outcomes
Leak pressure in 3 different head position in every patient (1st position will be randomized)
Time frame: 1 minute mechanical ventilation in predefined head position
incidence of failed 1st attempt insertion rate
Time frame: anaesthesia induction
incidence of overall laryngeal mask failure
Time frame: anaesthesia induction
incidence of the need for head reposition to obtain better airway seal in the 3 randomized head positions.
Time frame: Intraoperatively
Incidence of airway related complication
Time frame: From anaesthesia induction until dismission from postanaesthesia care unit
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 20 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Petr Stourac, prof. MD., Ph.D. study chair
Department of paediatric anaesthesia and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask insertion in people with Airway Management, run by Brno University Hospital at 1 site in Czechia.
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 4 inclusion and 6 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 20 May 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 Czechia. 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?
leak volume in 3 different head position in every patient (1st position will be randomized) (time frame: 1 minute mechanical ventilation in predefined head position). 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 20 May 2026.