Clinical trial NCT06891248: The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator Pilot Trial
Official title: The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Failure
Osteopathy in Diseases Classified Elsewhere
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time on ventilator
timeFrame: 90 days
Secondary outcomes:
measure: Ventilator associated measurement
timeFrame: 90 days
measure: Ventilator associated measurement
timeFrame: 90 days
measure: Ventilator associated measurement
timeFrame: 90 days
measure: Ventilator associated measurement
timeFrame: 90 days
measure: Ventilator associated measurement
timeFrame: 90 days
measure: Ventilator associated measurement
timeFrame: 90 days
measure: Blood pressure
timeFrame: 90 days
measure: Ventilator associated measurement
timeFrame: 90 days
measure: Mental status
timeFrame: 90 days
measure: Reintubation
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: OSU CHS
name: Amber Hood, DFS
role: STUDY_DIRECTOR
References: