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NCT Number: NCT06891248

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manipulative Treatment

Procedure

See treatment arm

Primary outcomes

  1. Time on ventilator

    Time frame: 90 days

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

Secondary outcomes

  1. Ventilator associated measurement

    Time frame: 90 days

    VBG/ABG

  2. Ventilator associated measurement

    Time frame: 90 days

    Negative inspiratory force (NIF)

  3. Ventilator associated measurement

    Time frame: 90 days

    Rapid Shallow Breathing Index (RSBI)

  4. Ventilator associated measurement

    Time frame: 90 days

    Airway occlusion pressure (P0.1)

  5. Ventilator associated measurement

    Time frame: 90 days

    Fraction of inspired oxygen (FiO2)

  6. Ventilator associated measurement

    Time frame: 90 days

    Positive end-expiratory pressure (PEEP)

  7. Blood pressure

    Time frame: 90 days

    Blood pressure

  8. Ventilator associated measurement

    Time frame: 90 days

    Spontaneous Tidal Volume (Spontaneous TV)

  9. Mental status

    Time frame: 90 days

    Whether awake and oriented x 3

  10. Reintubation

    Time frame: 90 days

    Reintubation after extubation

  11. Mortality

    Time frame: 90 days

    Death

Study contacts

Contact information is provided by the study sponsor or research team.

Cameron Henderson, DO

CONTACT

[email protected]

5804840849

Leslie Ching, DO

CONTACT

[email protected]

540-818-2801

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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