跳至主要内容
临床试验/NCT04208984
NCT04208984尚未招募不适用

Interactive Multimedia Diversion Device With Breath Control

University of Utah1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
试验地点
1
主要终点
End-tidal oxygen at the beginning of anesthesia

研究概览

简要总结

The experience for many children who need to undergo anesthesia induction by breathing anesthetic vapors in the operating room is frightening to the child. We have developed a computer-based game system that uses breathing-in and breathing-out as a game controller. We believe that the immersive game experience will encourage breathing patterns ideal for anesthetic induction while providing fun and diversion for the child, lessening or eliminating the fear that typically accompanies breathing anesthetics.

The purpose of the study is to determine whether diversion and breathing encouragement offered by a game and this device

详细描述

Anesthetic induction in children often requires pre-induction administration of pharmacologic sedatives to directly soothe the anxiety of the child (patient) as well as indirectly soothe the vicarious anxiety of the parents. The sterile, foreign environment, the parade of unfamiliar uniformed health-care workers, the sober weightiness of the adults' in their approach to the preparation for surgery, and the often cold, loud, and different smelling environment all contribute to an escalating level of anxiety. This anxiety manifests as a fear of separation (between child and parent) and a physiologic elevation in catecholamine release (fight or flight response: tachycardia, tachypnea, hypertension, sweating, crying, and escape behavior).

Pharmacologic sedatives are effective but have substantial drawbacks. They may be challenging to administer. They are distasteful and/or uncomfortable for the children to receive. They frequently have half-lives that extend beyond the length of surgery. They require 30 minutes to one-hour to take full effect. And, they may lead to more confusion or delirium upon emergence.

Distraction by the anesthesiologist, whether through storytelling, by entertaining with humor, by singing to the child, or by utilizing a computer, phone, or tablet device to provide games or videos, has been an effective tool and/or alternative to pharmacologic sedation for children to help smooth the experience of separation and the experience of undergoing anesthetic induction.1-3 In contrast to children, induction of anesthesia in adults is routinely accomplished by administration of intravenous medications. The intravenous route provides the most rapid and least sensory repugnant initiation of anesthesia. Starting an intravenous line in an awake child can be technically challenging for the physician and emotionally frightening and physically painful for the child. Because of that, for elective pediatric surgeries, the anesthesiologist often opts to initiate anesthesia in children by having the child breath anesthetic vapors (inhalation induction). Inhalation induction is dependent on the breathing of the patient for medication delivery. When children are anxious they often "breath-hold" and fight to avoid the anesthetic delivery circuit when presented with an anesthetic mask. This not only delays and complicates anesthetic delivery, it is uncomfortable and frustrating experience for the patient and for the anesthesiologist, and emotionally uncomfortable for the operating room health care team to observe. Providing a child with a non-frightening motivation to breathe through the facemask and anesthesia circuit would speed the delivery of anesthetic during induction and improve the experience for all involved. In addition, induction of anesthesia in adults is almost always preceded with a two to four minute "pre-oxygenation" period during which time the adult breathes 100% oxygen through the facemask and anesthetic circuit. The intent is to exchange the residual air in the lungs (the functional reserve capacity) with oxygen, providing a physical reservoir of life-extending oxygen should ventilating or intubating the patient prove difficult. This safety measure is not practical in children since they often reject breathing through the mask. If breathing through the mask was seen as an enjoyable aspect of a game rather than as a frightening preliminary step toward surgery, children might participate in pre-oxygenation thereby increasing the safety margin during induction of anesthesia.

We are creating an inexpensive gaming system that would provide an immersive distraction and would simultaneously encourage effective breathing through the anesthesia circuit by combining selected or original computer games with an engineered adaptor that turns breathing into the game controller.

A respiratory flow sensor is connected to a laptop computer and controls a simple computer game, where, e.g., a rocket ship flying through space can be made to swerve to the left or the right, depending on how much the subject inhales or exhales. The goal of the game is to collect virtual 'coins' by steering the rocket ship through them. The computer game is designed to keep the subject engaged and motivates the subject to breathe through the mask. During an initial phase at the very beginning of the game, the software detects the normal level of the subject's breathing. During the actual game the 'coins' are spaced in the game to ensure that the subject's breathing does not deviate by more than +-30% from their normal breathing level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 4-11 year old children undergoing anesthesia for any procedure

排除标准

  • Visual impairment
  • non english speaking
  • Premature infants
  • children previously exposed to the chemotherapeutic agent bleomycin

结局指标

主要结局

End-tidal oxygen at the beginning of anesthesia

时间窗: Measured directly after induction

End-tidal oxygen concentration measured at the start of anesthesia

Anxiety

时间窗: Administered to the anesthesiologist caring for the patient directly after induction of anesthesia

Anxiety measured by the PROMIS Anxiety Parent-Proxy questionnaire, minimum 0, maximum 100 points (t-score), higher score means higher anxiety

次要结局

未报告次要终点

研究者

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

Ben Chortkoff

Professor

University of Utah

研究点 (1)

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