Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04208984 |
| Other study ID # |
104924 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2024 |
| Est. completion date |
October 1, 2026 |
Study information
| Verified date |
January 2024 |
| Source |
University of Utah |
| Contact |
Ami Stuart, PhD |
| Phone |
8017934800 |
| Email |
ami.stuart[@]hsc.utah.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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
Description:
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.
