The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator Pilot Trial (NCT06891248) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator Pilot Trial
20 participantsStarted 2025-03-17
Plain-language summary
The objectives of this research are to determine the treatment effect size of OMM to wean patients off of the ventilator, determine the number of patients needed for a larger study (power), determine the willingness of patients/POAs to be recruited, identify the correct dosing of OMM and whether there are concerns for the safety of treatment, and determine whether the hypothesis is feasible for a larger study. The primary outcome measure is the duration of time until a subject is weaned off of mechanical ventilation using Osteopathic Manipulative Medicine (OMM). The secondary outcome measures (see the next section for further explanation) are to determine if OMM affects changes in morbidity and mortality, such as VBG/ABG, NIF, RSBI, P 0.1, FiO2, PEEP, mental status, hemodynamic stability (blood pressure), spontaneous TV, reintubation after extubation, and death.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Acute respiratory failure (hypoxic, hypercapnic, or neuromuscular)
✓. Not making satisfactory progress with weaning after being on the ventilator for more than 48 hours
✓. Clinical stability for pressure support trial with ventilator to monitor ventilation progression
✓. Pulmonology must be following the patient for standardized ventilator management approach and interventions as needed
✓. Medical power of attorney (POA) or legally authorized representative (LAR) who is able to consent subject for trial enrollment and treatment
✓. Patients who were not referred to the OMM service
Exclusion criteria
✕. Age less than 18 years old or more than 85 years old
✕. BMI\>60
✕. Moderate/severe neurological disease with expectation of non-progression off the ventilator or poor quality of life predicted (including end-stage dementia with the expectation of non-progression off ventilator, multiple sclerosis, ALS, anoxic brain injury, etc)
What they're measuring
1
Time on ventilator
Timeframe: 90 days
Trial details
NCT IDNCT06891248
SponsorOklahoma State University Center for Health Sciences