NCT06236542

Brief Summary

The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are:

  • What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group?
  • What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group?
  • What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group?
  • What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions.
  • Experimental group 1 will receive suctionings using automated robotic suctioning device.
  • Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system.
  • Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system.
  • Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Oct 2027

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
3.7 years until next milestone

Study Start

First participant enrolled

October 1, 2027

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

January 24, 2024

Last Update Submit

January 24, 2024

Conditions

Tracheostomy

Keywords

TracheostomyTracheostomy educationImmersive learningSimulationVirtual realityMixed realityRoboticsTracheostomy suctioningTracheostomy tube changePatient safetyCritical care

Outcome Measures

Primary Outcomes (2)

  • Number of Successful first-time tracheostomy tube changes

    successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device; from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation.

    An average of 6 weeks

  • Percent of Successful Atraumatic suctionings

    successful first-time tracheostomy tube change attempt, will be calculated by measuring the number of successful first-time tracheostomy tube change attempts over the total number of tracheostomy tube change attempts; from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation.

    An average of 6 weeks

Secondary Outcomes (15)

  • Discomfort as assessed by a Visual Analog Pain Scale

    During tracheostomy suctioning

  • Discomfort as assessed by the Wong-Baker FACES Pain Rating Scale

    During tracheostomy suctioning

  • Occurrence of Stomal Infection

    At time of receiving tracheostomy up to approximately 6 weeks

  • Occurrence of airway bleeding complications

    During tracheostomy suctionings

  • Occurrence of Tracheostomy tube dislodgments

    During procedure up to 6 weeks

  • +10 more secondary outcomes

Study Arms (4)

Automated tracheostomy suctioning device

EXPERIMENTAL

Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device.

Device: NextGen automated tracheostomy suctioning device

Mixed-reality tracheostomy tube change system

EXPERIMENTAL

Participants in this group will receive tracheostomy tube changes using a mixed-reality tracheostomy tube change device.

Device: NextGen mixed-reality tracheostomy tube change system

NextGen Tracheostomy Toolkit

EXPERIMENTAL

Participants in this group will receive tracheostomy care using the NextGen Tracheostomy Toolkit. Providers will be trained using virtual reality educational modules. Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device and tracheostomy tube changes using a mixed-reality tracheostomy tube change device.

Device: NextGen Tracheostomy Toolkit

Control group

NO INTERVENTION

Participants in this group will receive usual tracheostomy care.

Interventions

NextGen automated tracheostomy suctioning deviceDEVICE

Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctionings using an automated robotic suctioning device.

Automated tracheostomy suctioning device
NextGen mixed-reality tracheostomy tube change systemDEVICE

Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy tube changes using the mixed reality tracheostomy tube change system.

Mixed-reality tracheostomy tube change system
NextGen Tracheostomy ToolkitDEVICE

Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctioning using the robotic suctioning device; and tracheostomy tube changes using the mixed reality tracheostomy tube change system.

NextGen Tracheostomy Toolkit

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients 18 years or older
  • those who received a tracheostomy during their hospital stay
  • those who were admitted to the hospital with a tracheostomy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (4)

  • Martin KA, Cole TDK, Percha CM, Asanuma N, Mattare K, Hager DN, Brenner MJ, Pandian V. Standard versus Accelerated Speaking Valve Placement after Percutaneous Tracheostomy: A Randomized Controlled Feasibility Study. Ann Am Thorac Soc. 2021 Oct;18(10):1693-1701. doi: 10.1513/AnnalsATS.202010-1282OC.

    PMID: 33760713RESULT

  • McGrath BA, Wallace S, Lynch J, Bonvento B, Coe B, Owen A, Firn M, Brenner MJ, Edwards E, Finch TL, Cameron T, Narula A, Roberson DW. Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals. Br J Anaesth. 2020 Jul;125(1):e119-e129. doi: 10.1016/j.bja.2020.04.064. Epub 2020 May 31.

    PMID: 32493580RESULT

  • Cherney RL, Pandian V, Ninan A, Eastman D, Barnes B, King E, Miller B, Judkins S, Smith AE 4th, Smith NM, Hanley J, Creutz E, Carlson M, Schneider KJ, Shever LL, Casper KA, Davidson PM, Brenner MJ. The Trach Trail: A Systems-Based Pathway to Improve Quality of Tracheostomy Care and Interdisciplinary Collaboration. Otolaryngol Head Neck Surg. 2020 Aug;163(2):232-243. doi: 10.1177/0194599820917427. Epub 2020 May 26.

    PMID: 32450771RESULT

  • Brenner MJ, Pandian V, Milliren CE, Graham DA, Zaga C, Morris LL, Bedwell JR, Das P, Zhu H, Lee Y Allen J, Peltz A, Chin K, Schiff BA, Randall DM, Swords C, French D, Ward E, Sweeney JM, Warrillow SJ, Arora A, Narula A, McGrath BA, Cameron TS, Roberson DW. Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. Br J Anaesth. 2020 Jul;125(1):e104-e118. doi: 10.1016/j.bja.2020.04.054. Epub 2020 May 23.

    PMID: 32456776RESULT

Study Officials

  • Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC

    Johns Hopkins University School of Nursing

    PRINCIPAL INVESTIGATOR

  • Michael J Brenner, MD, FACS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC

CONTACT

443-655-3482vpandia1@jhu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Because blinding of participants and investigators is not practical, all groups will be aware of their respective treatment protocols, which will be considered in the analysis and interpretation of outcomes.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: NextGen Tracheostomy Toolkit
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start (Estimated)

October 1, 2027

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Due to privacy reasons.

Locations

US(2)