TracheostomyTRACHEASNCT06236542
Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety
A study testing NextGen automated tracheostomy suctioning device, NextGen mixed-reality tracheostomy tube change system and NextGen Tracheostomy Toolkit in people with Tracheostomy, run by Johns Hopkins University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy
- What is being tested?
- NextGen automated tracheostomy suctioning device, NextGen mixed-reality tracheostomy tube change system and NextGen Tracheostomy Toolkit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2027to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48104
Michael J Brenner, MD, FACS, 734-369-0204, mbren@med.umich.edu
Michael J Brenner, MD, FACS
Johns Hopkins University
Baltimore, Maryland, 21205
Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC, 443-655-3482, vpandia1@jhu.edu
Axel Mathias, PhD
About this study
Official title: NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care
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.
- Conditions
- Tracheostomy
- Being tested
- NextGen automated tracheostomy suctioning device, NextGen mixed-reality tracheostomy tube change system, NextGen Tracheostomy Toolkit
- Keywords
- Tracheostomy, Tracheostomy education, Immersive learning, Simulation, Virtual reality, Mixed reality, Robotics, Tracheostomy suctioning, Tracheostomy tube change, Patient safety, Critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Automated tracheostomy suctioning device | Experimental | Participants in this group will receive tracheostomy suctioning using an automated robotic suctioning device. Receives: 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. Receives: 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. Receives: Device: NextGen Tracheostomy Toolkit |
| Control group | No intervention | Participants in this group will receive usual tracheostomy care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: An average of 6 weeks
Secondary outcomes (15)
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.
Measured: During tracheostomy suctioning
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.
Measured: During tracheostomy suctioning
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.
Measured: At time of receiving tracheostomy up to approximately 6 weeks
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.
Measured: During tracheostomy suctionings
Occurrence of Tracheostomy tube dislodgments
Dislodgment will be observed during the tracheostomy tube change procedure, until discharge, or tracheostomy decannulation, or captured from electronic health records.
Measured: During procedure up to 6 weeks
Occurrence of False tract
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.
Measured: During procedure
Occurrence of Airway Obstruction
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.
Measured: An average of 6 weeks
Occurrence of Ventilator-associated pneumonia
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.
Measured: An average of 6 weeks
Patient/family satisfaction
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.
Measured: Immediately after procedure
Patient/family acceptability
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.
Measured: Immediately after procedure
Equitable delivery of care as assessed by summary of demographic factors
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.
Measured: Immediately after procedure
Intensive care unit length of stay (LOS)
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.
Measured: An average of 6 weeks
Hospital length of stay
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.
Measured: An average of 6 weeks
Duration of mechanical ventilation
The number of days patient received mechanical ventilation via a tracheostomy.
Measured: Approximately 2 weeks
Tracheostomy duration
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.
Measured: An average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Oct 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- NextGen Tracheostomy Toolkit
- Masking
- None (open label)
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC, Principal investigator, Johns Hopkins University School of NursingMichael J Brenner, MD, FACS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236542
- Sponsor's protocol ID
- IRB00430139
- Acronym
- TRACHEAS
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Due to privacy reasons.
Publications
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.
PubMed 33760713McGrath 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.
PubMed 32493580Cherney 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.
PubMed 32450771Brenner 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.
PubMed 32456776
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care
- ClinicalTrials.gov ID
- NCT06236542
- Acronym / sponsor ID
- TRACHEAS / IRB00430139
- Conditions
- Tracheostomy
- Keywords
- Tracheostomy, Tracheostomy education, Immersive learning, Simulation, Virtual reality, Mixed reality, Robotics, Tracheostomy suctioning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Oct 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- NextGen Tracheostomy Toolkit
| Arm | Type | Receives |
|---|---|---|
| Automated tracheostomy suctioning device | Experimental | Device: NextGen automated tracheostomy suctioning deviceParticipants in this group will receive tracheostomy suctioning using an automated robotic suctioning device. |
| Mixed-reality tracheostomy tube change system | Experimental | Device: NextGen mixed-reality tracheostomy tube change systemParticipants in this group will receive tracheostomy tube changes using a mixed-reality tracheostomy tube change device. |
| NextGen Tracheostomy Toolkit | Experimental | Device: NextGen Tracheostomy ToolkitParticipants 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. |
| Control group | No intervention | –Participants in this group will receive usual tracheostomy care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NextGen automated tracheostomy suctioning deviceProviders will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctionings using an automated robotic suctioning device. | Device | Automated tracheostomy suctioning device |
| NextGen mixed-reality tracheostomy tube change systemProviders 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. | Device | Mixed-reality tracheostomy tube change system |
| NextGen Tracheostomy ToolkitProviders 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. | Device | NextGen Tracheostomy Toolkit |
Primary outcome
Number of Successful first-time tracheostomy tube changes
Time frame: 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
Time frame: 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.
15 secondary outcomes
Discomfort as assessed by a Visual Analog Pain Scale
Time frame: During tracheostomy suctioning
Discomfort as assessed by the Wong-Baker FACES Pain Rating Scale
Time frame: During tracheostomy suctioning
Occurrence of Stomal Infection
Time frame: At time of receiving tracheostomy up to approximately 6 weeks
Occurrence of airway bleeding complications
Time frame: During tracheostomy suctionings
Occurrence of Tracheostomy tube dislodgments
Time frame: During procedure up to 6 weeks
Occurrence of False tract
Time frame: During procedure
Occurrence of Airway Obstruction
Time frame: An average of 6 weeks
Occurrence of Ventilator-associated pneumonia
Time frame: An average of 6 weeks
Patient/family satisfaction
Time frame: Immediately after procedure
Patient/family acceptability
Time frame: Immediately after procedure
Equitable delivery of care as assessed by summary of demographic factors
Time frame: Immediately after procedure
Intensive care unit length of stay (LOS)
Time frame: An average of 6 weeks
Hospital length of stay
Time frame: An average of 6 weeks
Duration of mechanical ventilation
Time frame: Approximately 2 weeks
Tracheostomy duration
Time frame: An average of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Results publication: PubMed 33760713Martin 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.
- Results publication: PubMed 32493580McGrath 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.
- Results publication: PubMed 32450771Cherney 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.
- Results publication: PubMed 32456776Brenner 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.
- Individual participant dataSharing planned: No. Due to privacy reasons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC principal investigator
Johns Hopkins University School of Nursing
Michael J Brenner, MD, FACS principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NextGen automated tracheostomy suctioning device, NextGen mixed-reality tracheostomy tube change system and NextGen Tracheostomy Toolkit in people with Tracheostomy, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinciya Pandian, PhD, MBA, MSN, RN, ACNP-BC (443-655-3482, vpandia1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Successful first-time tracheostomy tube changes (time frame: An average of 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236542, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.