- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424070
Glottic View in Infants With a Shoulder Roll
Effect of a Shoulder Roll on the Glottic View in Infants
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14222-2006
- Women and Children's Hospital of Buffalo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
The POGO score assesses the percent of the glottic opening that can be seen with and without the shoulder roll.
Other Names:
|
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.
|
Placebo
|
What is the study measuring?
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
Time Frame: One day
|
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
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)
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jerrold Lerman, Women & Children's Hospital/ Great Lakes Anesthesiology
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Infant Shoulder Roll
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intubation;Difficult
-
Lazarski UniversityCompletedIntubation; Difficult or Failed | Difficult Airway | Intubation;DifficultPoland
-
Catharina Ziekenhuis EindhovenCompletedAnesthesia Intubation Complication | Intubation; Difficult | Failed or Difficult Intubation | Failed or Difficult Intubation, Initial EncounterNetherlands
-
Michael MaRecruitingDifficult Intubation | Difficult Airway IntubationIreland
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntubation Complication | Intubation;Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Singapore
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)RecruitingIntubation Complication | Intubation; Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Japan, Italy, New Zealand, Singapore, Australia, Austria, Germany, India, United Kingdom
-
J. Matthias WalzTerminatedSurgery | Difficult Intubation | Anesthesia | Difficult Airway Intubation | Speech DysfunctionUnited States
-
Derince Training and Research HospitalCompletedDifficult Intubation | Difficult AirwayTurkey
-
University at BuffaloTerminatedIntubation Complication | Intubation;DifficultUnited States
-
University Hospitals Coventry and Warwickshire...Oxford University Hospitals NHS TrustCompletedIntubation;Difficult | Tracheal IntubationUnited Kingdom
-
Heinrich-Heine University, DuesseldorfCompleted
Clinical Trials on Shoulder Roll
-
Radford UniversityCompletedMusculoskeletal Equilibrium | PostureUnited States
-
Samsun Education and Research HospitalCompleted
-
Kuwait UniversityCompletedTime | Patient Preference | RetentionKuwait
-
Instituto Nacional de Cancerologia, ColumbiaCompleted
-
University Hospital of Mont-GodinneCompleted
-
Mahidol UniversityUnknownPancreatic Fistula | Periampullary CarcinomaThailand
-
Medtronic EndovascularCompletedGreat Saphenous Vein (GSV) With Venous Reflux DiseaseUnited States
-
University of Illinois at Urbana-ChampaignUnknownFall Injury | Fall Prevention | Fall Safety
-
Zafer Cavit Cehreli, DDS, PhDUnknownDental Caries in Children | Dental Caries on Pit and Fissure Surface | Dental LeakageUnited States
-
California State University, Dominguez HillsCompletedMyofascial Pain SyndromesUnited States