Clinical trial NCT06236542: Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety
Official title: NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tracheostomy
Keywords: Tracheostomy
Tracheostomy education
Immersive learning
Simulation
Virtual reality
Mixed reality
Robotics
Tracheostomy suctioning
Tracheostomy tube change
Patient safety
Critical care
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NextGen Tracheostomy Toolkit
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

  1. Experimental group 1 will receive suctionings using automated robotic suctioning device.
  2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system.
  3. 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.
  4. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Successful first-time tracheostomy tube changes
timeFrame: An average of 6 weeks
measure: Percent of Successful Atraumatic suctionings
timeFrame: An average of 6 weeks
Secondary outcomes:
measure: Discomfort as assessed by a Visual Analog Pain Scale
timeFrame: During tracheostomy suctioning
measure: Discomfort as assessed by the Wong-Baker FACES Pain Rating Scale
timeFrame: During tracheostomy suctioning
measure: Occurrence of Stomal Infection
timeFrame: At time of receiving tracheostomy up to approximately 6 weeks
measure: Occurrence of airway bleeding complications
timeFrame: During tracheostomy suctionings
measure: Occurrence of Tracheostomy tube dislodgments
timeFrame: During procedure up to 6 weeks
measure: Occurrence of False tract
timeFrame: During procedure
measure: Occurrence of Airway Obstruction
timeFrame: An average of 6 weeks
measure: Occurrence of Ventilator-associated pneumonia
timeFrame: An average of 6 weeks
measure: Patient/family satisfaction
timeFrame: Immediately after procedure
measure: Patient/family acceptability
timeFrame: Immediately after procedure
measure: Equitable delivery of care as assessed by summary of demographic factors
timeFrame: Immediately after procedure
measure: Intensive care unit length of stay (LOS)
timeFrame: An average of 6 weeks
measure: Hospital length of stay
timeFrame: An average of 6 weeks
measure: Duration of mechanical ventilation
timeFrame: Approximately 2 weeks
measure: Tracheostomy duration
timeFrame: An average of 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Michael J Brenner, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.