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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Subjects in these arms only receive conventional care | |
| Osteopathic Manipulative Treatment | Experimental | The standard OMM treatment arm includes a 10-minute treatment time for 5 body regions with up to 3 providers working on the patient simultaneously. The OMM attending physician will be physically present and supervising the treatment, and may be participating in the treatment. The 5 body regions include Head, Neck, Thoracic, Ribs, and Abdominal/Diaphragm. The standard technique for the OMM arm includes OA decompression, screening and treating any cervical dysfunction, thoracic inlet myofascial release, rib raising, thoracic paraspinal inhibition, and abdominal diaphragm myofascial release. There is an opportunity for an additional 5 minutes of treatment time and additional regions if the lead physician determines it is appropriate based on clinical judgment. The additional 4 regions include Upper Extremity, Lower Extremity, Lumbar, Pelvis, and Sacrum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manipulative Treatment | Procedure | See treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time on ventilator | Number of days that the patient is on the ventilator after inclusion in the study | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator associated measurement | VBG/ABG | 90 days |
| Ventilator associated measurement | Negative inspiratory force (NIF) | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leslie Ching, DO | Contact | 540-818-2801 | leslie.ching@okstate.edu | |
| Cameron Henderson, DO | Contact | 5804840849 | cameron.henderson@okstate.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amber Hood, DFS | OSU CHS | Study Director |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Ventilator associated measurement | Rapid Shallow Breathing Index (RSBI) | 90 days |
| Ventilator associated measurement | Airway occlusion pressure (P0.1) | 90 days |
| Ventilator associated measurement | Fraction of inspired oxygen (FiO2) | 90 days |
| Ventilator associated measurement | Positive end-expiratory pressure (PEEP) | 90 days |
| Blood pressure | Blood pressure | 90 days |
| Ventilator associated measurement | Spontaneous Tidal Volume (Spontaneous TV) | 90 days |
| Mental status | Whether awake and oriented x 3 | 90 days |
| Reintubation | Reintubation after extubation | 90 days |
| Mortality | Death | 90 days |
| D012046 | Rehabilitation |