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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
See treatment arm
Time on ventilator
Number of days that the patient is on the ventilator after inclusion in the study
Time frame: 90 days
Ventilator associated measurement
VBG/ABG
Time frame: 90 days
Ventilator associated measurement
Negative inspiratory force (NIF)
Time frame: 90 days
Ventilator associated measurement
Rapid Shallow Breathing Index (RSBI)
Time frame: 90 days
Ventilator associated measurement
Airway occlusion pressure (P0.1)
Time frame: 90 days
Ventilator associated measurement
Fraction of inspired oxygen (FiO2)
Time frame: 90 days
Ventilator associated measurement
Positive end-expiratory pressure (PEEP)
Time frame: 90 days
Blood pressure
Blood pressure
Time frame: 90 days
Ventilator associated measurement
Spontaneous Tidal Volume (Spontaneous TV)
Time frame: 90 days
Mental status
Whether awake and oriented x 3
Time frame: 90 days
Reintubation
Reintubation after extubation
Time frame: 90 days
Mortality
Death
Time frame: 90 days
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