Glottic View in Infants With a Shoulder Roll

NCT ID: NCT03424070

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-18
• Study Completion Date: 2018-05-05

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.

Conditions

Intubation;Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Shoulder Roll

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

No shoulder roll (placebo)

Intervention Type: OTHER

Placebo

Interventions

Shoulder Roll

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

Intervention Type: OTHER

No shoulder roll (placebo)

Placebo

Intervention Type: OTHER

Other Intervention Names

jelly roll

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Jerrold Lerman

Clinical Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerrold Lerman

Role: PRINCIPAL_INVESTIGATOR

Women & Children's Hospital/ Great Lakes Anesthesiology

Locations

Women and Children's Hospital of Buffalo

Buffalo, New York, United States

Countries

United States

References

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)

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.

Reference Type: BACKGROUND

PMID: 28139308 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25684039 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32925342 (View on PubMed)

Other Identifiers

Infant Shoulder Roll

Identifier Type: -

Identifier Source: org_study_id