ICU physiotherapy under the microscope: can we measure its true cost?
NCT ID NCT07361419
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how much energy critically ill patients on ventilators use during routine passive physiotherapy. By measuring oxygen consumption with a special device in the breathing tube, researchers hope to understand the physical demands of these exercises. The goal is to help doctors prescribe safer, more individualized rehabilitation for ICU patients.
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 study could help doctors tailor physiotherapy for ICU patients based on their actual metabolic response, making rehabilitation safer and more personalized.
- What could go wrong
- This is a small observational study with only 40 participants, so results may not apply to all ICU patients. It measures short-term metabolic changes, not long-term outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2026
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
Adult critically ill patients admitted to the intensive care unit who require invasive mechanical ventilation and receive routine supine physiotherapy as part of standard care. The study population includes both deeply sedated patients undergoing passive mobilization and awake or lightly sedated patients able to perform active-assisted mobilization, allowing characterization of metabolic responses across different levels of consciousness and participation.
- 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: * Adults aged 18 years or older. * Admission to the intensive care unit. * Invasive mechanical ventilation via endotracheal tube or tracheostomy. * Ability to remain in the supine position during the measurement period. * Clinical indication for supine physiotherapy as part of usual ICU care. * Richmond Agitation-Sedation Scale (RASS) score between -5 and 0 at the time of the session. * Hemodynamic stability, defined as mean arterial pressure ≥65 mmHg with or without vasopressor support and no initiation or increase \>20% in vasopressor dose within the previous 60 minutes. * Respiratory stability, defined as no changes in ventilator settings within the previous 30 minutes and oxygen saturation ≥90% with FiO₂ ≤0.60 and PEEP ≤12 cmH₂O. * Technical conditions allowing valid indirect calorimetry measurement (absence of significant air leaks and no planned circuit disconnections). Exclusion Criteria: * Use of extracorporeal membrane oxygenation (ECMO) or other extracorporeal gas exchange systems. * Continuous renal replacement therapy during the measurement period when it may interfere with metabolic measurements. * Significant air leaks in the airway or ventilator circuit that invalidate indirect calorimetry measurements. * Planned procedures or interventions during the measurement period that could interfere with gas exchange (e.g., bronchoscopy, recruitment maneuvers, ventilator setting changes). * Severe respiratory instability requiring FiO₂ \>0.60 or PEEP \>12 cmH₂O. * Ongoing neuromuscular blockade infusion. * Clinical contraindications to limb mobilization (e.g., unstable fractures, active bleeding, uncontrolled intracranial hypertension). * Agitation or risk of unplanned device removal (RASS \>0). * Refusal of participation by the patient or legally authorized representative, when applicable.
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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.
Contacts and locations
Locations
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Hospital Universitario de Badajoz
Badajoz, Badajoz, 06006, Spain
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