Health TrialsbyHealthPanel

Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety

ConditionTracheostomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorJohns Hopkins University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

none

Trial design

Design model

Parallel

Treatments tested in this trial

  • NextGen automated tracheostomy suctioning device

    Device

    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.

  • NextGen mixed-reality tracheostomy tube change system

    Device

    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.

  • NextGen Tracheostomy Toolkit

    Device

    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.

Treatment groups

632 Participants
are divided into 4 treatment groups
Group A: Automated tracheostomy suctioning deviceExperimental treatment 1 intervention
Group B: Mixed-reality tracheostomy tube change systemExperimental treatment 1 intervention
Group C: NextGen Tracheostomy ToolkitExperimental treatment 1 intervention
Group D: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
An average of 6 weeks
2

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.

Time frame
An average of 6 weeks

Secondary outcomes

1

Discomfort as assessed by a Visual Analog Pain Scale

Discomfort, the level of physical or psychological unease, pain, or distress experienced by patients with a tracheostomy resulting from the presence of the tracheostomy tube or related interventions will be measured using a Visual Analog Scale pain scale. The scale ranges from 0 - 100 with 0 referring to no pain and 100 extreme pain.

Time frame
During tracheostomy suctioning
2

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

Discomfort, the level of physical or psychological unease, pain, or distress experienced by patients with a tracheostomy resulting from the presence of the tracheostomy tube or related interventions will be measured using a Wong-Baker FACES Pain Rating Scale if the patient cannot verbalize pain levels using Visual Analog Scale pain scale. The Wong-Baker FACES Pain Rating scale consists of a series of varying facial expressions, ranging from a happy face (indicating no pain) to a crying, distressed face (indicating severe pain). Each face on the scale is assigned a numerical value (often ranging from 0 to 10), which allows for quantification and tracking of pain over time.

Time frame
During tracheostomy suctioning
3

Occurrence of Stomal Infection

The occurrence of infection at the stoma site in the neck where tracheostomy tube is inserted, will be assessed by the presence of swelling, redness, discharge, and pain at the stoma site from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation.

Time frame
At time of receiving tracheostomy up to approximately 6 weeks
4

Occurrence of airway bleeding complications

Data regarding bleeding in the airway secretions due to injury from suctioning will be retrieved from electronic health records and automated suctioning device.

Time frame
During tracheostomy suctionings

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: