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NCT Number: NCT05035264

Head Position for Laryngeal Mask Air Leak and Performance in Paediatric Patients (Neutral, Sniffing and Beyond Sniffing Position)

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

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Key information

Conditions

Airway Management

Age range

2 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brno University Hospital

Brno, South Moravian, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 2-19 years
  • Informed consent
  • Elective airway management
  • laryngeal mask for airway management

Exclusion criteria

  • 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

Treatment and study plan

Laryngeal mask insertion

Device

Laryngeal mask insertion in neutral position

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. incidence of failed 1st attempt insertion rate

    Time frame: anaesthesia induction

    incidence of failed 1st attempt insertion rate

  3. incidence of overall laryngeal mask failure

    Time frame: anaesthesia induction

    incidence of overall laryngeal mask failure

  4. incidence of the need for head reposition to obtain better airway seal in the 3 randomized head positions.

    Time frame: Intraoperatively

    incidence of the need for head reposition to obtain better airway seal in the 3 randomized head positions

  5. Incidence of airway related complication

    Time frame: From anaesthesia induction until dismission from postanaesthesia care unit

    Incidence of airway related complication -regurgitation/aspiration, desaturation, oesophageal intubation, laryngeal/airway injury incidence

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Collaborators

  • Masaryk University

Registry information

Official study title

Head Position for Laryngeal Mask Air Leak and Performance in Paediatric Patients (Neutral, Sniffing and Beyond Sniffing Position): Prospective Randomized Trial

Acronym: SNIFFLMA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2021
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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