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

Diversion Device With Breath Control

Induction of Anesthesia

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.

      Except for the flow-sensor, which is connected in-line between the standard face mask and the
      standard breathing circuit, the anesthetic equipment is the same that is routinely used on
      patients. The system does not display any respiratory measurements to the anesthesia provider
      taking care of the patient and no clinical or dosing decisions are based on the system's
      involvement or output. The system does record the breathing signals in an internal file for
      later off-line analysis, but that data is de-identified and not made available to the
      clinician taking care of the subject.

Study

Music Video

Interactive Multimedia Diversion Device With Breath Control

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

End-tidal oxygen concentration measured at the start of anesthesia

Professor

Patients randomized to this group will receive standard of care induction of anesthesia

Patients randomized to this group will receive induction of anesthesia using the Lullabreath game

Patients randomized to this group will receive induction of anesthesia using the music video game

Diversion Device With Breath Control

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status