Breath analysis may offer a Needle-Free way to track critical Acid-Base balance
NCT ID NCT07782658
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This study tests whether a non-invasive device called indirect calorimetry—which measures carbon dioxide production and elimination through breathing—can accurately reflect changes in blood bicarbonate levels in critically ill patients. Currently, bicarbonate is measured through repeated blood draws, which are invasive and discontinuous. The researchers hypothesize that the mismatch between CO₂ production and elimination correlates with bicarbonate shifts. If confirmed, this could lead to continuous, non-invasive monitoring of acid-base status in the ICU, potentially improving patient care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Indirect calorimetry measurement (a non-invasive device that measures gas exchange to estimate metabolism)
- What this could lead to
- If confirmed, this could enable continuous, non-invasive monitoring of blood bicarbonate in ICU patients, reducing the need for repeated blood draws and allowing faster clinical adjustments.
- What could go wrong
- This is a small, early-stage study (91 patients) testing a hypothesis. The correlation may be weak or not hold in real-world conditions, and the device's accuracy could be affected by patient factors or ventilator settings.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 91 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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 admitted to the ICU
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Adult patient admitted to the ICU within the past 72 hours * Receiving invasive mechanical ventilation * For whom the treating clinician plans to perform at least two blood bicarbonate measurements within the next 6 hours * No objection from the participant or their next of kin Exclusion Criteria: * Planned weaning from invasive mechanical ventilation or ventilator change before the second bicarbonate measurement * Conditions interfering with the interpretation of indirect calorimetry data: * Inspiratory oxygen fraction \> 60% * Administration of inhaled medications, including nitric oxide * Positive end-expiratory pressure (PEEP) \> 15 cmH₂O * Excessive leaks in the ventilator circuit, defined as expired volume \< 95% of inspired volume * Patient on mechanical circulatory support with a gas exchanger, or planned initiation before the second blood gas analysis * Patient on extracorporeal renal replacement therapy, or planned initiation before the second bicarbonate measurement * Patient who received sodium bicarbonate within 2 hours prior to inclusion, or planned administration before the second bicarbonate measurement * Frequent disconnections of the ventilator circuit, or planned bronchoscopy before the second bicarbonate measurement
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, Rhone, 69500, France
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