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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
Sponsor:
Information provided by (Responsible Party):
Jerrold Lerman, State University of New York at Buffalo

Tracking Information
First Submitted Date  ICMJE October 17, 2017
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date May 15, 2018
Actual Study Start Date  ICMJE February 18, 2018
Actual Primary Completion Date May 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glottic View in Infants With a Shoulder Roll
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Intubation;Difficult
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 5, 2018
Actual Primary Completion Date May 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03424070
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Jerrold Lerman, State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jerrold Lerman Women & Children's Hospital/ Great Lakes Anesthesiology
PRS Account State University of New York at Buffalo
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP