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

NCT ID: NCT04410289

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-12-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Management Infant ALL Children, Only Endotracheal Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aman Kalra, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26227445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21596871 (View on PubMed)

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. doi: 10.1177/0310057X0803601s05.

Reference Type BACKGROUND
PMID: 18724555 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 20086071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22110497 (View on PubMed)

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. doi: 10.1381/0960892042386869.

Reference Type BACKGROUND
PMID: 15527629 (View on PubMed)

Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.

Reference Type BACKGROUND
PMID: 2917111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26986776 (View on PubMed)

Vialet R, Nau A, Chaumoitre 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.

Reference Type BACKGROUND
PMID: 18363622 (View on PubMed)

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. doi: 10.1097/00000542-199712000-00005.

Reference Type BACKGROUND
PMID: 9416711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20846964 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13188

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.