Osteopathy in Diseases Classified Elsewhere, Respiratory Failure
Conditions
Brief 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.
Interventions
PROCEDUREOsteopathic Manipulative Treatment
See treatment arm
Sponsors
Oklahoma State University Center for Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Acute respiratory failure (hypoxic, hypercapnic, or neuromuscular) 2. Not making satisfactory progress with weaning after being on the ventilator for more than 48 hours 3. Clinical stability for pressure support trial with ventilator to monitor ventilation progression 4. Pulmonology must be following the patient for standardized ventilator management approach and interventions as needed 5. Medical power of attorney (POA) or legally authorized representative (LAR) who is able to consent subject for trial enrollment and treatment 6. Patients who were not referred to the OMM service
Exclusion criteria
1. Age less than 18 years old or more than 85 years old 2. BMI\>60 3. 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) 4. Status epilepticus or EEG result pending 5. Post-arrest hypothermia protocol 6. Acute stroke 7. Acute rib fractures preventing the implementation of the treatment protocol 8. Acute spinal injury preventing the implementation of the treatment protocol 9. Recent head injury requiring close clinical monitoring 10. Ejection Fraction less than 15% 11. Pleural effusion requiring procedural intervention or inhibiting ventilator progress 12. Pericardial effusion or tamponade requiring procedural intervention or inhibiting ventilator progress 13. ACLS/cardiac arrest within the past 72 hours 14. Confirmed opioid overdose with positive urine drug screen and response to naloxone 15. Patients who were referred to the OMM service
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time on ventilator | 90 days | Number of days that the patient is on the ventilator after inclusion in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator associated measurement | 90 days | VBG/ABG |
| Blood pressure | 90 days | Blood pressure |
| Mental status | 90 days | Whether awake and oriented x 3 |
| Reintubation | 90 days | Reintubation after extubation |
| Mortality | 90 days | Death |
Contacts
Primary ContactLeslie Ching, DO
Backup ContactCameron Henderson, DO
Outcome results
None listed