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

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

Study Overview

• Status: Recruiting
• Conditions: Airway Management
• Intervention / Treatment: Device: Laryngeal mask insertion; Device: Laryngeal mask insertion; Device: Laryngeal mask insertion

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milan Kratochvíl, MD. EDIC; Phone Number: 00420 532234696; Email: kratochvil.milan@fnbrno.cz
• Study Contact Backup: Name: Jozef Klučka, assoc.prof.MD., Ph.D.; Phone Number: 00420 532234686; Email: klucka.jozef@fnbrno.cz

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Recruiting
      • Brno University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neutral head position; Laryngeal mask will be inserted after anaesthesia induction in neutral head position	Device: Laryngeal mask insertion; Laryngeal mask insertion in neutral position; Device: Laryngeal mask insertion; Laryngeal mask insertion in sniffing position; Device: Laryngeal mask insertion; Laryngeal mask insertion in beyond sniffing position
Active Comparator: Sniffing position; Laryngeal mask will be inserted after anaesthesia induction in sniffing head position	Device: Laryngeal mask insertion; Laryngeal mask insertion in neutral position; Device: Laryngeal mask insertion; Laryngeal mask insertion in sniffing position; Device: Laryngeal mask insertion; Laryngeal mask insertion in beyond sniffing position
Experimental: Beyond sniffing position; Laryngeal mask will be inserted after anaesthesia induction in sniffing head position	Device: Laryngeal mask insertion; Laryngeal mask insertion in neutral position; Device: Laryngeal mask insertion; Laryngeal mask insertion in sniffing position; Device: Laryngeal mask insertion; Laryngeal mask insertion in beyond sniffing position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 minute mechanical ventilation in predefined head position

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 minute mechanical ventilation in predefined head position
incidence of failed 1st attempt insertion rate	incidence of failed 1st attempt insertion rate	anaesthesia induction
incidence of overall laryngeal mask failure	incidence of overall laryngeal mask failure	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	Intraoperatively
Incidence of airway related complication	Incidence of airway related complication -regurgitation/aspiration, desaturation, oesophageal intubation, laryngeal/airway injury incidence	From anaesthesia induction until dismission from postanaesthesia care unit

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Masaryk University
• Investigators: Study Chair: Petr Stourac, prof. MD., Ph.D., Department of paediatric anaesthesia and intensive care medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Laryngeal mask airway; Head position; Paediatric patient; Supraglottic Airway Devices
• Other Study ID Numbers: KDAR SNIFF LMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No