Glottic View in Infants With a Shoulder Roll

NCT03424070 | Completed DMC

• 1 other identifier: Infant Shoulder Roll
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the distance from the operating table to the eye of the laryngoscopist while intubating the trachea with or without a shoulder roll. A photo of the glottic opening will compare the glottic views in both positions.

Conditions

Intubation;Difficult

Keywords

laryngoscopy; pediatric; airway; gel roll; larynx; glottis

Outcome Measures

Primary Outcomes (1)

• The height from the anesthesiologist's (cm) eye to the table top with and without a shoulder roll

  Height in centimeters from the lateral canthus of the eye of the anesthesiologist to the table top.

  One day

Secondary Outcomes (1)

• The view of the glottic opening (in percent) with and without a shoulder roll

  1 day

Study Arms (2)

Laryngoscopy view with a shoulder roll

ACTIVE COMPARATOR

The primary outcome is the difference in the height of the lateral canthus of the eyelid of the laryngoscopist above the OR table during laryngoscopy with and then without the shoulder roll. These two positions will be compared using photos of the best glottic view taken during laryngoscopy with a shoulder roll in place. Then a photo of the best glottic view will be taken during laryngoscopy without the shoulder roll in place. These two views will be compared by a blinded anesthesiologist using the POGO scale.

Other: Shoulder Roll

Laryngoscopy without a shoulder roll

PLACEBO COMPARATOR

The primary outcome is the difference in the height of the lateral canthus of the eyelid of the laryngoscopist above the OR table during laryngoscopy without and then with the shoulder roll. These two positions will be compared using photos of the best glottic view taken during laryngoscopy with a shoulder roll in place. Then a photo of the best glottic view will be taken during laryngoscopy without the shoulder roll in place. These two views will be compared by a blinded anesthesiologist using the POGO scale.

Other: No shoulder roll (placebo)

Interventions

Shoulder Roll OTHER

The POGO score assesses the percent of the glottic opening that can be seen with and without the shoulder roll.

Also known as: jelly roll

Laryngoscopy view with a shoulder roll

No shoulder roll (placebo) OTHER

Placebo

Laryngoscopy without a shoulder roll

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• months of age
• American Society of Anesthesiologists (ASA) I-II
• Elective non-airway surgery under general anesthesia

You may not qualify if:

• Emergency surgeries
• Patients in whom difficult airway is expected
• Obese patients in whom BMI \>95 percentile for age
• Patients with untreated gastroesophageal reflux
• Full stomach patients

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222-2006, United States

Location

Related Publications (4)

• 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.

  PMID: 20846964 BACKGROUND

• Kim EH, Ji SH, Song IK, Lee JH, Kim JT, Kim HS. Simple method for obtaining the optimal laryngoscopic view in children: A prospective observational study. Am J Emerg Med. 2017 Jun;35(6):867-870. doi: 10.1016/j.ajem.2017.01.048. Epub 2017 Jan 24.

  PMID: 28139308 BACKGROUND

• Black AE, Flynn PE, Smith HL, Thomas ML, Wilkinson KA; Association of Pediatric Anaesthetists of Great Britain and Ireland. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatr Anaesth. 2015 Apr;25(4):346-62. doi: 10.1111/pan.12615. Epub 2015 Feb 16.

  PMID: 25684039 BACKGROUND

• Alfahel W, Gopinath A, Arheart KL, Gensler T, Lerman J. The Effects of a Shoulder Roll During Laryngoscopy in Infants: A Randomized, Single-Blinded, Crossover Study. Anesth Analg. 2020 Oct;131(4):1210-1216. doi: 10.1213/ANE.0000000000004802.

  PMID: 32925342 DERIVED

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jerrold Lerman

  Women & Children's Hospital/ Great Lakes Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator who measures the height between the lateral canthus of the eye of the anesthesiologist to the table top will be blinded to the presence of a shoulder roll. The evaluator who will review the final photos of the laryngeal inlet will be blinded to the order of the positioning.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology

Model Details: All children will undergo laryngoscopy with and without a shoulder roll (randomly assigned) during which photos will be taken of the larynx. The views will be compared using the POGO scale. Contemporaneously, the anesthesiologist's height from the table top to the lateral canthus of left eye.

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: February 6, 2018
• Study Start: February 18, 2018
• Primary Completion: May 5, 2018
• Study Completion: May 5, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)