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

Airway Management Clinical Trial

— SNIFFLMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05035264
• Other study ID #: KDAR SNIFF LMA
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Brno University Hospital
• Contact: Jozef Klucka, assoc.prof.MD., Ph.D.
• Phone: 532234686
• Email: klucka.jozef[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• Laryngeal mask insertion
Laryngeal mask insertion in neutral position
• Laryngeal mask insertion
Laryngeal mask insertion in sniffing position
• Laryngeal mask insertion
Laryngeal mask insertion in beyond sniffing position

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	incidence of failed 1st attempt insertion rate	incidence of failed 1st attempt insertion rate	anaesthesia induction
Secondary	incidence of overall laryngeal mask failure	incidence of overall laryngeal mask failure	anaesthesia induction
Secondary	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
Secondary	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