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临床试验/NCT03424070
NCT03424070已完成不适用

Effect of a Shoulder Roll on the Glottic View in Infants

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
The height from the anesthesiologist's (cm) eye to the table top with and without a shoulder roll

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
1 Day 至 1 Year(Child)
性别
All
接受健康志愿者
是

入选标准

  • •0-12 months of age
  • •American Society of Anesthesiologists (ASA) I-II
  • •Elective non-airway surgery under general anesthesia

排除标准

  • •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

研究组 & 干预措施

Laryngoscopy view with a shoulder roll

Active Comparator

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.

干预措施: Shoulder Roll (Other)

Laryngoscopy without a shoulder roll

Placebo Comparator

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.

干预措施: No shoulder roll (placebo) (Other)

结局指标

主要结局

The height from the anesthesiologist's (cm) eye to the table top with and without a shoulder roll

时间窗: One day

Height in centimeters from the lateral canthus of the eye of the anesthesiologist to the table top.

次要结局

  • The view of the glottic opening (in percent) with and without a shoulder roll(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerrold Lerman

Clinical Professor of Anesthesiology

State University of New York at Buffalo

研究点 (1)

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