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New device aims to prevent mouth sores and tube slippage in elderly ICU patients

NCT ID NCT07684443

Disease control Sponsor: Norther Private Collage of Nursing Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial tests whether a special device (AnchorFast) can better secure breathing tubes in elderly trauma patients compared to standard tape. The goal is to reduce painful mouth injuries and prevent the tube from slipping out. Ninety patients aged 65 and older in the intensive care unit will be randomly assigned to one of three securing methods.

What this could mean

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

Active substance
AnchorFast endotracheal tube securement device
What this could lead to
If effective, this device could become a standard way to secure breathing tubes in elderly ICU patients, reducing painful mouth sores and accidental tube removal.
What could go wrong
This is a small, early-stage trial with only 90 patients, so results may not apply to all hospital settings. The device may not significantly outperform tape.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

90 people

The number who actually took part.

Started

Dec 2025

Finished

May 2026

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.

Ages

65 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Inclusion Criteria 1. Age ≥65 years old and more. 2. Newly admission to trauma ICU following traumatic injury 3. Patient attached with EET and mechanical ventilation 4. Expected duration of mechanical ventilation for 72 hours and more. 5. Hemodynamically stable (MAP ≥65 mmHg with or without vasopressors) 6. Informed consent obtained from patient or legally authorized representative 7. Enrollment within 6 hours of intubation Exclusion Criteria: * Extubation: 1. Pre-existing tracheostomy and planned tracheostomy within 72 hours 2. Patients with facial trauma or facial burns or active facial skin. 3. Known allergy to adhesive materials or device components 4. Active facial skin infection or significant dermatologic condition 5. Enrollment in another interventional study 6. Do-not-resuscitate status or comfort care designation 7. Expected survival less than 72 hours based on clinical judgment 8. Oral surgery or oral infection or inflammation. 9. A previous neck injury, projecting upper teeth, or the absence of teeth. 10. Radiotherapy-induced oral mucositis.

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As listed by the trial registrant

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

Elderly Trauma icu patients

Contacts and locations

Locations

  • Norther Private Colleague of Nursing

    Arar, Saudi Arabia

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