Glottic View in Infants With a Shoulder Roll
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|ClinicalTrials.gov Identifier: NCT03424070|
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intubation;Difficult||Other: Shoulder Roll Other: No shoulder roll (placebo)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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.|
|Official Title:||Effect of a Shoulder Roll on the Glottic View in Infants|
|Actual Study Start Date :||February 18, 2018|
|Actual Primary Completion Date :||May 5, 2018|
|Actual Study Completion Date :||May 5, 2018|
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.
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
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.
Other: No shoulder roll (placebo)
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424070
|United States, New York|
|Women and Children's Hospital of Buffalo|
|Buffalo, New York, United States, 14222-2006|
|Principal Investigator:||Jerrold Lerman||Women & Children's Hospital/ Great Lakes Anesthesiology|