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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Osteopathic Manipulative Treatment

    Procedure/Surgery

    See treatment arm

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Osteopathic Manipulative TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time on ventilator

Number of days that the patient is on the ventilator after inclusion in the study

Time frame
90 days

Secondary outcomes

1

Ventilator associated measurement

VBG/ABG

Time frame
90 days
2

Ventilator associated measurement

Negative inspiratory force (NIF)

Time frame
90 days
3

Ventilator associated measurement

Rapid Shallow Breathing Index (RSBI)

Time frame
90 days
4

Ventilator associated measurement

Airway occlusion pressure (P0.1)

Time frame
90 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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