The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator Pilot Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorOklahoma State University Center for Health Sciences

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Osteopathic Manipulative Treatment

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations