Tracheostomy
Conditions
Keywords
Tracheostomy, Tracheostomy education, Immersive learning, Simulation, Virtual reality, Mixed reality, Robotics, Tracheostomy suctioning, Tracheostomy tube change, Patient safety, Critical care
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.
Interventions
DEVICENextGen automated tracheostomy suctioning 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.
DEVICENextGen mixed-reality tracheostomy tube change system
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.
DEVICENextGen Tracheostomy Toolkit
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.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
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.
Intervention model description
NextGen Tracheostomy Toolkit
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successful first-time tracheostomy tube changes | An average of 6 weeks | 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. |
| Percent of Successful Atraumatic suctionings | An average of 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Stomal Infection | At time of receiving tracheostomy up to approximately 6 weeks | 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. |
| Occurrence of airway bleeding complications | During tracheostomy suctionings | Data regarding bleeding in the airway secretions due to injury from suctioning will be retrieved from electronic health records and automated suctioning device. |
| Occurrence of Tracheostomy tube dislodgments | During procedure up to 6 weeks | Dislodgment will be observed during the tracheostomy tube change procedure, until discharge, or tracheostomy decannulation, or captured from electronic health records. |
| Occurrence of False tract | During procedure | False Tract, the creation of an unintended passage during tracheostomy tube insertion will be identified by the study team during tracheostomy tube change procedure based on the assessment for air leakage, suboptimal ventilation, or visible defects, using capnography and pulsoximetry, and/or radiological findings. |
| Occurrence of Airway Obstruction | An average of 6 weeks | Airway Obstruction, partial or complete blockage of the tracheostomy tube, will be assessed by monitoring signs and symptoms of airway obstruction, such as decreased airflow or increased respiratory effort from the time of receiving a tracheostomy tube, until discharge or tracheostomy decannulation. |
| Occurrence of Ventilator-associated pneumonia | An average of 6 weeks | Ventilator-associated pneumonia (VAP) caused by microbial colonization in the airways will be evaluated for correlation with use of tracheostomy to differentiate from other causes of VAP based on timing of diagnoses and clinical symptoms by evaluating electronic health records. VAP will be assessed from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation. |
| Discomfort as assessed by a Visual Analog Pain Scale | During tracheostomy suctioning | 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. |
| Patient/family acceptability | Immediately after procedure | Patient and family satisfaction will be measured using a questionnaire with Likert scale items and semi-structured interviews. Acceptability will be assessed immediately after use of automated robotic suctioning device, mixed-reality tracheostomy tube change system, or NextGen tracheostomy toolkit. |
| Equitable delivery of care as assessed by summary of demographic factors | Immediately after procedure | Evaluate equitable delivery of care among different patient groups, by summarizing socio-demographic factors such as gender, race, ethnicity, and insurance status to evaluate associations in relation to clinical outcomes. Equitable delivery of care will be assessed immediately after use of automated robotic suctioning device, mixed-reality tracheostomy tube change system, or NextGen tracheostomy toolkit. |
| Intensive care unit length of stay (LOS) | An average of 6 weeks | ICU LOS is the number of days the patient remains in the ICU with a tracheostomy tube from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation. |
| Hospital length of stay | An average of 6 weeks | Hospital LOS is the number of days a patient remains in the hospital, including both the ICU and other units, with a tracheostomy tube from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation. |
| Duration of mechanical ventilation | Approximately 2 weeks | The number of days patient received mechanical ventilation via a tracheostomy. |
| Tracheostomy duration | An average of 6 weeks | Tracheostomy duration is the length of time the tracheostomy tube remains in place, indicating the duration of tracheostomy dependence; from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation. |
| Patient/family satisfaction | Immediately after procedure | Patient and family satisfaction will be measured using a study team-developed satisfaction questionnaire with 10 Likert scale items and semi-structured interviews. The Likert scale will range from 1 - 5 with 1 being strongly disagree and 5 being strongly agree. Satisfaction will be assessed immediately after use of automated robotic suctioning device, mixed-reality tracheostomy tube change system, or NextGen tracheostomy toolkit. |
| Discomfort as assessed by the Wong-Baker FACES Pain Rating Scale | During tracheostomy suctioning | 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. |
Countries
United States
Contacts
Primary ContactVinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC
Outcome results
None listed