Glottic View in Infants With a Shoulder Roll

• ClinicalTrials.gov Identifier: NCT03424070
• Recruitment Status: Completed
• First Posted: February 6, 2018
• Last Update Posted: May 15, 2018
• Sponsor: State University of New York at Buffalo
• Information provided by (Responsible Party): Jerrold Lerman, State University of New York at Buffalo

Tracking Information

• First Submitted Date: October 17, 2017
• First Posted Date: February 6, 2018
• Last Update Posted Date: May 15, 2018
• Actual Study Start Date: February 18, 2018
• Actual Primary Completion Date: May 5, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 3, 2018)

The height from the anesthesiologist's (cm) eye to the table top with and without a shoulder roll [ Time Frame: One day ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 3, 2018)

The view of the glottic opening (in percent) with and without a shoulder roll [ Time Frame: 1 day ]

The view of glottic opening with and without a shoulder roll (secondary outcome) will be compared in photos and measured as a percent of the full length of normal vocal cords (from a standard photograph)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Glottic View in Infants With a Shoulder Roll
• Official Title: Effect of a Shoulder Roll on the Glottic View in Infants
• 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.

Detailed Description

On the day of the surgery, healthy infants will be evaluated by an anesthesiologist for a preoperative clearance and suitability for inclusion in the study. If the infants are eligible, the parents will receive a detailed explanation of the study that is written into the consent form. Written consent will be obtained from those parents who are willing to enroll their children in the study. After consent, the concealed randomization code for the next subject in the study will be opened to determine the sequence of the positioning as described below.

The infants will be unpremedicated. In the operating room, anesthesia will be induced using a standard inhalational induction (that includes, 70 % nitrous oxide and 30 % oxygen followed by 8% sevoflurane). Upon the loss of eyelash reflex, ventilation will be assisted and intravascular (IV) access will be secured. Once IV access is established, Propofol, 3 mg/kg will be administered and the lungs ventilated with 8% sevoflurane in 100% oxygen for 1 minute. The randomization code will then determine the order of the laryngoscopy: either no shoulder roll or a 2 inch shoulder roll first, then the alternative position. For both positions, direct laryngoscopy using a #1 size straight Miller blade will expose the larynx to obtain the optimal glottic view. At this point, the distance from the lateral canthus of the eye of the anesthesiologist to the level of the table will be recorded (distance A) using a standard measure anchored on the operating room table top and a photo of the glottic opening will be taken using a high-quality digital hand-held camera. This photo will be referred to as photo 1. The shoulder roll will either be removed or inserted under the shoulders (based on the randomization) while the anesthesiologist holds the laryngoscopic view of the larynx. The anesthesiologist's head will then move (if necessary) up or down to establish the optimal view of the larynx again and the distance from the lateral canthus of the eye of the anesthesiologist to the table top will again be measured (distance B). A photo of the laryngoscopy view (photo 2) will be taken. The entire laryngoscopy will take less than 30 seconds. If the child desaturates to less than 93%, the study will be aborted and the lungs ventilated. An anesthesiologist, who is blind to the study hypothesis, will evaluate the photos of the glottis view the Percent of Glottic Opening scale (POGO) in 10% increments. The primary outcome will be the distance from the lateral canthus of the anesthesiologist's eye to the level of the table with and without a shoulder roll (distance A and distance B) will be compared using paired t-test. (P<0.05 will be accepted). The secondary outcome will be the glottic views (photos 1 and picture 2) compared using the Kruskall Wallis test.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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.

Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Other

• Condition: Intubation;Difficult

Intervention

• Other: Shoulder Roll
  The POGO score assesses the percent of the glottic opening that can be seen with and without the shoulder roll.
  Other Name: jelly roll
• Other: No shoulder roll (placebo)
  Placebo

Study Arms

• Active Comparator: Laryngoscopy view with a shoulder roll
  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.
  Intervention: Other: Shoulder Roll
• Placebo Comparator: Laryngoscopy without a shoulder roll
  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.
  Intervention: Other: No shoulder roll (placebo)

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 3, 2018): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 5, 2018
• Actual Primary Completion Date: May 5, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 0-12 months of age
• American Society of Anesthesiologists (ASA) I-II
• Elective non-airway surgery under general anesthesia

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 1 Year (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03424070
• Other Study ID Numbers: Infant Shoulder Roll
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Jerrold Lerman, State University of New York at Buffalo
• Study Sponsor: State University of New York at Buffalo
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jerrold Lerman; Women & Children's Hospital/ Great Lakes Anesthesiology

• PRS Account: State University of New York at Buffalo
• Verification Date: May 2018