Defining the 'Sniffing Position" in Infants and Toddlers - A Pilot Study

Not Applicable

Completed

• Conditions: Airway Management; Infant ALL; Children, Only; Endotracheal Intubation
• Interventions: Procedure: Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation; Procedure: Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation

• Registration Number: NCT04410289
• Lead Sponsor: Tufts Medical Center

Brief Summary

The "sniffing position" is widely accepted as a favorable position for direct laryngoscopy (DL) in both pediatric and adult patients. External anatomical markers are well documented to confirm proper 'sniffing position' in adults, but data on their use in the pediatric population is sparse. The investigators propose to define these markers in young children and investigate whether patients positioned using this standardized approach have better intubating conditions than those positioned randomly per the preference of the anesthesiologist.

Detailed Description

The procedure of endotracheal intubation in adults and children is a continuum, and begins with proper head positioning prior to direct laryngoscopy (DL). It is an accepted paradigm that proper positioning optimizes intubating conditions, and decreases subsequent airway maneuvers and manipulation.

The sniffing position is an accepted airway positioning concept in pediatric airway management, and continues to be recommended by experts and textbooks in the field. Anatomical peculiarities such as the large head relative to the torso in infants and toddlers is assumed to put the head in proper position when gently extended. However, reproducible parameters to confirm optimal head positioning remain vague and unclear. In the absence of objective and measurable markers, practitioners position infants and toddlers according to their individual preferences, and as such the procedure lacks definition and objective clarity.

The investigators plan to recruit 40 healthy patients between the ages of 1 month - 48 months and randomize them to be positioned either according to a predetermined algorithm or positioned freely according to the provider's preference. Patients randomized to the intervention group will be positioned with the aim to horizontally align the external auditory meatus (EAM) with the sternal notch (SN).

In summary, the study aims to define the sniffing position for infants and toddlers using reproducible objective secondary markers, and investigate whether a systematic approach to positioning using such markers improves direct laryngoscopic outcomes in the young pediatric patient population.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-26
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-27
• Status Verified: 2020-06
• Study First Posted: 2020-06-01
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• healthy infants and toddlers undergoing non-emergent surgery under general anesthesia with an oral endotracheal tube

Exclusion Criteria

• neonates (infants under 1 month of age), infants and toddlers with congenital syndromes affecting the airway, and patients undergoing emergency surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation	After induction of general anesthesia, and prior to direct laryngoscopy, patients in the control group were positioned freely according to the provider's preference. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed.
Intervention Group	Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation	After induction of general anesthesia, and prior to direct laryngoscopy, patients in the intervention group were positioned using props horizontally aligning the external auditory meatus (EAM) with the sternal notch (SN) and the chin with the sinciput. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed.

Primary Outcome Measures

Name	Time	Method
Difference in Intubation Difficulty Scale (IDS) Score	The brief time involved (5-10 minutes) involving the process of head positioning, direct laryngoscopy and endotracheal intubation.	To assess the difference in IDS scores between the study and control groups

Secondary Outcome Measures

Name	Time	Method
Angles of Deviation of the EAM-SN plane and Chin-Sinciput Plane from the Horizontal	Post-hoc analysis using a computer program to calculate angles. 10 minutes per patient.	Secondary outcome was to analyze and compare the degree of alignment or nonalignment of the EAM-SN plane and the sinciput-chin plane in both groups. Angles of deviation of the EAM-SN and chin-sinciput plane were measured in each cohort based on photographic data collected. A positive angle deviation indicated head flexion and a negative angle indicated head extension.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States