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

NCT05035264 | Unknown DMC

• 1 other identifier: KDAR SNIFF LMA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Airway Management

Keywords

Supraglottic Airway Devices; Laryngeal mask airway; Head position; Paediatric patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Leak pressure in 3 different head position in every patient (1st position will be randomized)

  1 minute mechanical ventilation in predefined head position

• incidence of failed 1st attempt insertion rate

  anaesthesia induction

• 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.

  Intraoperatively

• Incidence of airway related complication

  From anaesthesia induction until dismission from postanaesthesia care unit

Study Arms (3)

Neutral head position

ACTIVE COMPARATOR

Laryngeal mask will be inserted after anaesthesia induction in neutral head position

Device: Laryngeal mask insertion

Sniffing position

ACTIVE COMPARATOR

Laryngeal mask will be inserted after anaesthesia induction in sniffing head position

Device: Laryngeal mask insertion

Beyond sniffing position

EXPERIMENTAL

Laryngeal mask will be inserted after anaesthesia induction in sniffing head position

Device: Laryngeal mask insertion

Interventions

Laryngeal mask insertion DEVICE

Laryngeal mask insertion in neutral position

Beyond sniffing position; Neutral head position; Sniffing position

Eligibility Criteria

• Age: 2 Years - 19 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead
• Masaryk University: collaborator

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

RECRUITING

Study Officials

• Petr Stourac, prof. MD., Ph.D.

  Department of paediatric anaesthesia and intensive care medicine

  STUDY CHAIR

Central Study Contacts

Jozef Klučka, assoc.prof.MD., Ph.D.

CONTACT

532234686; klucka.jozef@fnbrno.cz

Milan Kratochvíl, MD. EDIC

CONTACT

532234696; kratochvil.milan@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Under general anaesthesia
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Paediatric patients (between 2-18 years) undergoing elective airway management without predicted/confirmed difficult airway with the laryngeal mask airway after anaesthesia induction

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 5, 2021
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

CZ (1)