Airway Management Clinical Trial
— SNIFFLMAOfficial 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
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Brno University Hospital | Brno | South Moravian Region |
Lead Sponsor | Collaborator |
---|---|
Brno University Hospital | Masaryk University |
Czechia,
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 |
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