Diversion Device With Breath Control

NCT ID: NCT04208984

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

Brief 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

Detailed 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.

Conditions

Induction of Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

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

No interventions assigned to this group

Study

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

Study

Intervention Type: DEVICE

After consent and assent the child and parent will be introduced the Lullabreath in pre-op. The purpose of Lullabreath will be explained and the Lullabreath will be taught (15 minutes). The parent will complete the PROMIS Proxy Anxiety short form. The children are then taken to the operating room (leave parents) with the Lullabreath. The anesthesiologist will hook the device up to the anesthesia circuit and start the Lullabreath. The child will then undergo induction of anesthesia while playing the Lullabreath.

Music Video

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

Music Video

Intervention Type: OTHER

After consent and assent the child and parent will be introduced to the game in pre-op. The purpose of the game will be explained and the game will be taught (15 minutes). The parent will complete the PROMIS Proxy Anxiety short form. The children are then taken to the operating room (leave parents) with the game. The anesthesiologist will hook the device up to the anesthesia circuit and start the game. The child will then undergo induction of anesthesia while playing the game. The child can choose to watch one of two music videos (Frozen, Lion King)

Interventions

Study

After consent and assent the child and parent will be introduced the Lullabreath in pre-op. The purpose of Lullabreath will be explained and the Lullabreath will be taught (15 minutes). The parent will complete the PROMIS Proxy Anxiety short form. The children are then taken to the operating room (leave parents) with the Lullabreath. The anesthesiologist will hook the device up to the anesthesia circuit and start the Lullabreath. The child will then undergo induction of anesthesia while playing the Lullabreath.

Intervention Type: DEVICE

Music Video

After consent and assent the child and parent will be introduced to the game in pre-op. The purpose of the game will be explained and the game will be taught (15 minutes). The parent will complete the PROMIS Proxy Anxiety short form. The children are then taken to the operating room (leave parents) with the game. The anesthesiologist will hook the device up to the anesthesia circuit and start the game. The child will then undergo induction of anesthesia while playing the game. The child can choose to watch one of two music videos (Frozen, Lion King)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Ben Chortkoff

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai Kuck, PhD

Role: STUDY_CHAIR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Central Contacts

Ami Stuart, PhD

Role: CONTACT

ami.stuart@hsc.utah.edu

8017934800

Facility Contacts

Jacob Steenblik, PhD

Role: primary

Jacob.Steenblik@nurs.utah.edu

801-581-6393

Other Identifiers

104924

Identifier Type: -

Identifier Source: org_study_id