Trial reportMedical sciences (Basel, Switzerland)2025
Feasibility of the Manual Diaphragm Release Technique in Neurocritical Patients on Mechanical Ventilation: A Pilot Randomized Controlled Trial.
Trial report in Medical sciences (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
8 authors.
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Abstract
introductionThis pilot randomized trial evaluated the feasibility of the Manual Diaphragm Release Technique (MDRT) in neurocritical patients on invasive mechanical ventilation (IMV) and explored its immediate effects on diaphragmatic kinematics to inform future trials.
methodsAdult neurocritical patients receiving IMV and ventilated in an assisted mode (pressure-support ventilation, PSV) at the time of enrollment were randomized to receive a single session of MDRT plus standard physiotherapy vs. a sham maneuver plus standard physiotherapy. The primary outcome was the feasibility of applying MDRT in neurocritical care patients under IMV, operationalized by the recruitment rate, protocol adherence, and incidence of intervention-related adverse events. The exploratory secondary outcomes were immediate diaphragmatic kinematics (contraction and relaxation velocities and inspiratory and expiratory excursions), which were measured by ultrasound to provide preliminary effect-size estimates for future trials.
resultsTwenty neurocritical patients (10 in each group) were randomized and all completed the protocol. Baseline characteristics were comparable between groups. The study demonstrated high feasibility with 80% recruitment rate, 100% adherence, and a mean intervention time of 6.2 ± 1.1 min. No adverse events were observed during or after the intervention. Adjusted analyses revealed no detectable differences in diaphragmatic kinematics between groups after the single session. The adjusted mean differences were 0.1 mm/s (95% CI: -0.3 to 0.5;
conclusionsMDRT was found to be feasible for use in neurocritical patients under mechanical ventilation. Although no immediate effects on diaphragm kinematics were detected, these preliminary findings support the rationale for larger, adequately powered trials to further investigate cumulative or long-term effects.
trial registrationThe trial is registered in ReBEC-Brazilian Registry of Clinical Trials under ID: RBR-3ngffwr.
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