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

June 1, 2020 updated by: Tufts Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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.
Procedure: Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation
Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation
Active Comparator: Control Group
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.
Procedure: Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation
Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The brief time involved (5-10 minutes) involving the process of head positioning, direct laryngoscopy and endotracheal intubation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-hoc analysis using a computer program to calculate angles. 10 minutes per patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Investigators

  • Principal Investigator: Aman Kalra, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 26, 2019

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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