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Tiny study checks if head angle skews ventilator readings

NCT ID NCT02816359

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at whether the angle of a patient's head (flat at 0° or raised at 30°) changes the esophageal pressure reading used to set ventilators. Eleven adults with acute respiratory distress syndrome (ARDS) had their pressures measured in both positions. The goal was to see if position matters for accurate ventilator settings.

What this could mean

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

What this could lead to
If successful, this could help doctors get more accurate measurements for setting ventilators in ARDS patients, potentially improving care.
What could go wrong
This is a very small, early study with only 11 participants, so results may not apply broadly. It only measures pressure differences, not patient outcomes.

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

11 people

The number who actually took part.

Started

May 2016

Finished

Sep 2017

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

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 * Acute respiratory failure defined by PaO2/FIO2\< 300 mmHg or pH\<7,35 and pCO2\>45mmHg or Moderate or severe Accurate Respiratory Distress Syndrome ARDS defined by: * New or worsening respiratory symptoms in the previous week. * Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or Nodules * Respiratory failure not fully explained by cardiac failure or fluid overload * PaO2/FIO2\< 200 mmHg and PEEP ≥ 5 cm H2O and VT ≤6 ml/kg of Ideal Body Weight * Patient intubated or tracheotomized and receiving mechanical ventilation * Indication of esophageal measurement decided by the clinician Exclusion Criteria: * Contraindication to naso-gastric tube insertion : * Recent gastro-duodenal ulcer * Stage III esophageal varices * Refractory intracranial hypertension * Unstabilized spine fracture * Surgical contraindication * Burns on more than 20 % of the body surface * Underlying disease with a life expectancy of less than one year * End-of-life decision before inclusion * Pregnant or breast-feeding patients * Subject deprived of freedom, minor, subject under a legal protective measure * Research team unavailability * Lack of medical care plan

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

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

Acute respiratory distress syndrome

Contacts and locations

Locations

  • Hôpital Croix-Rousse

    Lyon, 69004, France

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