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New online tool aims to ease tough decisions on breathing machines

NCT ID NCT07223918

Knowledge-focused Sponsor: Denver Health and Hospital Authority Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a personalized online decision-support tool called TRACH-Support. The tool is designed to help families and doctors make shared decisions about tracheostomy and prolonged mechanical ventilation. Researchers enrolled 105 participants, including family members of patients on breathing machines and medical providers, to evaluate how usable and acceptable the tool is. Participants reviewed the tool and completed surveys, with some also taking part in interviews.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TRACH-Support (online decision-support tool)
What this could lead to
If successful, this tool could help families and doctors make more informed, shared decisions about tracheostomy and prolonged breathing support.
What could go wrong
This is a small pilot study focused on usability and acceptability, not on patient outcomes. The tool may not improve decision quality or health results in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

105 people

The number who actually took part.

Started

Jan 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will focus on 2 broad groups. Surrogates - Almost all patients receiving mechanical ventilation lack decisional capacity. Therefore, all key medical decisions are made by surrogate decision-makers including decisions related to tracheostomy and PMV. We will recruit surrogate decision-makers identified by the primary medical team to evaluate TRACH-Support for patients who have received MV for 7 days or more or for whom a tracheostomy discussion is planned. Healthcare Team Members - early qualitative data indicates that decision-making often involves the entire healthcare team. Therefore, we will recruit providers, nurses, and respiratory therapists routinely involved in the care of patients receiving MV to evaluate TRACH-Support.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Surrogates * Age \>18 years * English or Spanish speaking * Surrogate decision-maker for a patient who has been receiving mechanical ventilation for greater than or equal to 7 days or in whom a tracheostomy discussion is planned. The role of surrogate decision-maker will be determined by the medical team (can be either a medical decision power of attorney (MDPOA) or proxy decision-maker). * As many decisions are made by a group of surrogates rather than a single surrogate, up to 3 surrogates per patient will be enrolled. Healthcare Team Members * Age \> 18 years * A critical care or palliative care physician (MD/DO), advanced practice provider (APP), nurse, or respiratory therapist who routinely engages in tracheostomy and PMV discussions Exclusion Criteria: Surrogates * Age \< 18 years * Non-English or Non-Spanish speaking * Prisoner Healthcare Team Members * Age \< 18 years * refuses to evaluate TRACH-Support * refuses to discuss alternatives to tracheostomy with families

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Conditions

The condition(s) this trial relates to.

acute respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory failure Mechanical ventilation Tracheostomy

Contacts and locations

Locations

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.