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Can targeted sedation help patients breathe easier on oxygen therapy?

NCT ID NCT07679932

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study looks at how two sedative drugs, dexmedetomidine and remifentanil, affect breathing effort in patients with acute hypoxemic respiratory failure who are receiving high-flow nasal oxygen. Researchers will measure changes in inspiratory effort and symptoms like shortness of breath and discomfort. The goal is to understand if tailored sedation can improve breathing patterns in these patients.

What this could mean

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

Active substance
dexmedetomidine and remifentanil
What this could lead to
If successful, this could help doctors better manage sedation to ease breathing effort in patients with respiratory failure.
What could go wrong
This is a small, observational study with only 40 participants, so results may not apply to all patients. The drugs may cause side effects like low blood pressure or slow breathing.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

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

Patients with hypoxemic respiratory failure treated with high-flow oxygen therapy for whom the attending physician, based on clinical indications, has decided to initiate sedative-analgesic treatment with dexmedetomidine or remifentanil. The study plans to enroll 40 patients, including 20 patients treated with dexmedetomidine and 20 patients treated with remifentanil.

Ages

18 years and older

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: * Age ≥18 years * PaO2/FiO2 ratio ≤ 200; * PaCO2 \< 45 mmHg; * At least one symptom prompting the use of sedative-analgesic drugs according to the prescription of the attending physician: dyspnea and/or discomfort equal of greater than 4/10 (Visual Analog Scale - VAS), respiratory rate equal or greater than 25 breaths per minute, PaCO2\<35 mmHg, pain (Numeric Rating Scale ≥ 4 or Behavioral Pain Scale - Non-Intubated ≥ 4); * Informed consent signature. Exclusion Criteria: * Pregnancy; * Exacerbation of asthma or chronic obstructive pulmonary disease; * Chronic lung disease, requiring oxygen therapy at home; * Cardiogenic pulmonary oedema; * Hemodynamic instability (systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) and/or lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed shock; * Metabolic acidosis (pH \<7.30 with normal or hypocarbia); * Glasgow Coma Scale \<13; * Contraindications to esophageal balloon and/or EIT placement.

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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.

AHRF

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A.Gemelli IRCCS

    Roma, RM, 00168, Italy

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