Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety
- Conditions
- Tracheostomy
- Interventions
- Device: NextGen automated tracheostomy suctioning deviceDevice: NextGen mixed-reality tracheostomy tube change systemDevice: NextGen Tracheostomy Toolkit
- Registration Number
- NCT06236542
- Lead Sponsor
- Johns Hopkins University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 632
- 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
- none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Automated tracheostomy suctioning device NextGen automated tracheostomy suctioning device Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device. Mixed-reality tracheostomy tube change system NextGen mixed-reality tracheostomy tube change system Participants in this group will receive tracheostomy tube changes using a mixed-reality tracheostomy tube change device. NextGen Tracheostomy Toolkit NextGen Tracheostomy Toolkit 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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.
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.
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 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.
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.
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.
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.
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.
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.
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.
Trial Locations
- Locations (2)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States