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Not yet recruiting NCT06891248

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

No phase Interventional Respiratory Failure Osteopathy in Diseases Classified Elsewhere

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Osteopathic Manipulative Treatment.
Who it may be relevant to
Registry conditions: Respiratory Failure, Osteopathy in Diseases Classified Elsewhere. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure Osteopathic Manipulative Treatment
    See treatment arm

Primary outcome measures

  • Time on ventilator [Time frame: 90 days]
Secondary outcome measures (11)
  • Ventilator associated measurement [Time frame: 90 days]
  • Ventilator associated measurement [Time frame: 90 days]
  • Ventilator associated measurement [Time frame: 90 days]
  • Ventilator associated measurement [Time frame: 90 days]
  • Ventilator associated measurement [Time frame: 90 days]
  • Ventilator associated measurement [Time frame: 90 days]
  • Blood pressure [Time frame: 90 days]
  • Ventilator associated measurement [Time frame: 90 days]
  • Mental status [Time frame: 90 days]
  • Reintubation [Time frame: 90 days]
  • Mortality [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06891248 · 2024193

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗