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Evaluation of the effects of Orthostatism in critical patients: a randomized double-blind clinical trial

Effects of Orthostatism in Comatose patients admitted to the ICU: a randomized, double-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6k7gfy4
Enrollment
Unknown
Registered
2025-10-05
Start date
2025-09-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration Artificial

Interventions

Methods: Randomized, controlled, prospective, double-blind clinical trial conducted in the Intensive Care Unit (ICU) of Hospital Estadual Dirceu Arcoverde (HEDA) between July 2025 and June 2028. The o

Sponsors

Universidade Federal do Delta do Parnaíba
Lead Sponsor
Hospital Estadual Dirceu Arcoverde - HEDA
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients admitted to the intensive care unit (ICU); of both sexes; aged 18 or over and 65 or under; who are on invasive mechanical ventilation (IMV) for at least twenty-four hours; in a coma of neurological or metabolic origin; with hemodynamic stability for carrying out the intervention

Exclusion criteria

Exclusion criteria: The study will not include patients under 18 years of age; patients with cardiac alterations confirmed by electrocardiogram (ECG); bronchopleural fistula; deep vein thrombosis; thrombocytopenia (below 50,000); body temperature above 37.8°C; orthopedic fractures in the lower limbs; orthopedic alterations that limit orthostatism; spinal cord injury; significant pressure injury in the calcaneus; use of intra-aortic balloon pump (IABP); intracranial pressure (ICP) monitoring catheter and/or external ventricular shunt (EVD); use of vasoactive drugs in high doses

Design outcomes

Primary

MeasureTime frame
It is expected to find a reduction in the time on mechanical ventilation and days of hospitalization by comparing with the control group and presenting the parameters. Evaluate the improvement in diagnosis and comorbidities and the SAPS 3 scale through data collection at the beginning of the study and at the end of the study based on the observation of a variation of at least 5% in pre- and post-intervention measurements

Secondary

MeasureTime frame
Evaluate age, hemodynamic parameters, and respiratory mechanics before, during, and after the intervention by collecting data, neurological evolution, motor response, time to regain consciousness using the Glasgow scale, level of agitation or sedation according to the Richmond Agitation-Sedation Scale (RASS) through its scale, diaphragm thickness in the immediate effect of orthostatism (1st day of protocol) and the effect after at least 3 sessions of orthostatism through ultrasound, incidence of complications such as hypotension, syncope, respiratory instability by collecting parameters at the beginning, during, and at the end of the intervention

Countries

Brazil

Contacts

Public ContactBaldomero da Silva

Universidade Federal do Delta do Parnaíba

baldomero@ufdpar.edu.br+55 (86) 995038693

Outcome results

None listed

Source: REBEC (via WHO ICTRP)