Skip to main content
OpenTrials
Completed

NCT Number: NCT04410289

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation

Procedure

Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation

Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation

Procedure

Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation

Primary outcomes

  1. Difference in Intubation Difficulty Scale (IDS) Score

    Time frame: 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 outcomes

  1. Angles of Deviation of the EAM-SN plane and Chin-Sinciput Plane from the Horizontal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

A Prospective Randomized Pilot Study to Define and Validate the Standard 'Sniffing Position' in Infants and Toddlers.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.