Status:
NOT_YET_RECRUITING
The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator Pilot Trial
Lead Sponsor:
Oklahoma State University Center for Health Sciences
Conditions:
Respiratory Failure
Osteopathy in Diseases Classified Elsewhere
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
- Status epilepticus or EEG result pending
- Post-arrest hypothermia protocol
- Acute stroke
- Acute rib fractures preventing the implementation of the treatment protocol
- Acute spinal injury preventing the implementation of the treatment protocol
- Recent head injury requiring close clinical monitoring
- Ejection Fraction less than 15%
- Pleural effusion requiring procedural intervention or inhibiting ventilator progress
- Pericardial effusion or tamponade requiring procedural intervention or inhibiting ventilator progress
- ACLS/cardiac arrest within the past 72 hours
- Confirmed opioid overdose with positive urine drug screen and response to naloxone
- Patients who were referred to the OMM service
Key Trial Info
Start Date :
March 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 8 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06891248
Start Date
March 17 2025
End Date
June 8 2025
Last Update
March 24 2025
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