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

Children, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410289
• Other study ID #: 13188
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 26, 2019

Study information

• Verified date: June 2020
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 26, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 48 Months

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management
• Children, Only
• Endotracheal Intubation
• Infant ALL

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. — View Citation

Akihisa Y, Hoshijima H, Maruyama K, Koyama Y, Andoh T. Effects of sniffing position for tracheal intubation: a meta-analysis of randomized controlled trials. Am J Emerg Med. 2015 Nov;33(11):1606-11. doi: 10.1016/j.ajem.2015.06.049. Epub 2015 Jun 23. Review. — View Citation

Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. — View Citation

El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19. Review. — View Citation

Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15. — View Citation

Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. — View Citation

Greenland KB, Eley V, Edwards MJ, Allen P, Irwin MG. The origins of the sniffing position and the Three Axes Alignment Theory for direct laryngoscopy. Anaesth Intensive Care. 2008 Jul;36 Suppl 1:23-7. Review. — View Citation

Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. — View Citation

Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448. — View Citation

Prakash S, Rapsang AG, Mahajan S, Bhattacharjee S, Singh R, Gogia AR. Comparative evaluation of the sniffing position with simple head extension for laryngoscopic view and intubation difficulty in adults undergoing elective surgery. Anesthesiol Res Pract. 2011;2011:297913. doi: 10.1155/2011/297913. Epub 2011 Oct 29. — View Citation

Vialet R, Nau A, Chaumoître K, Martin C. Effects of head posture on the oral, pharyngeal and laryngeal axis alignment in infants and young children by magnetic resonance imaging. Paediatr Anaesth. 2008 Jun;18(6):525-31. doi: 10.1111/j.1460-9592.2008.02530.x. Epub 2008 Mar 18. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Intubation Difficulty Scale (IDS) Score	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	Angles of Deviation of the EAM-SN plane and Chin-Sinciput Plane from the Horizontal	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.