Glottic View in Infants With a Shoulder Roll

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of a Shoulder Roll on the Glottic View in Infants

Conditions
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Intubation;Difficult

Intervention / Treatment
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* Other: Shoulder Roll
* Other: No shoulder roll (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laryngoscopy view with a shoulder roll<br>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<br>* The POGO score assesses the percent of the glottic opening that can be seen with and without the shoulder roll.<br>* Other names: jelly roll;|
| Placebo Comparator: Laryngoscopy without a shoulder roll<br>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)<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The view of the glottic opening (in percent) with and without a shoulder roll | 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) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, laryngoscopy, airway, gel roll, larynx, glottis