Respiratory FailureNCT06891248
The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator Pilot Trial
A study testing Osteopathic Manipulative Treatment in people with Respiratory Failure and Osteopathy in Diseases Classified Elsewhere, run by Oklahoma State University Center for Health Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Failure, Osteopathy in Diseases Classified Elsewhere
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2025to 8 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator
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.
- Being tested
- Osteopathic Manipulative Treatment
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
See treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects in these arms only receive conventional care |
| Osteopathic Manipulative Treatment | Experimental | The standard OMM treatment arm includes a 10-minute treatment time for 5 body regions with up to 3 providers working on the patient simultaneously. The OMM attending physician will be physically present and supervising the treatment, and may be participating in the treatment. The 5 body regions include Head, Neck, Thoracic, Ribs, and Abdominal/Diaphragm. The standard technique for the OMM arm includes OA decompression, screening and treating any cervical dysfunction, thoracic inlet myofascial release, rib raising, thoracic paraspinal inhibition, and abdominal diaphragm myofascial release.
There is an opportunity for an additional 5 minutes of treatment time and additional regions if the lead physician determines it is appropriate based on clinical judgment. The additional 4 regions include Upper Extremity, Lower Extremity, Lumbar, Pelvis, and Sacrum. Receives: Procedure: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time on ventilator
Number of days that the patient is on the ventilator after inclusion in the study
Measured: 90 days
Secondary outcomes (11)
Ventilator associated measurement
VBG/ABG
Measured: 90 days
Ventilator associated measurement
Negative inspiratory force (NIF)
Measured: 90 days
Ventilator associated measurement
Rapid Shallow Breathing Index (RSBI)
Measured: 90 days
Ventilator associated measurement
Airway occlusion pressure (P0.1)
Measured: 90 days
Ventilator associated measurement
Fraction of inspired oxygen (FiO2)
Measured: 90 days
Ventilator associated measurement
Positive end-expiratory pressure (PEEP)
Measured: 90 days
Blood pressure
Blood pressure
Measured: 90 days
Ventilator associated measurement
Spontaneous Tidal Volume (Spontaneous TV)
Measured: 90 days
Mental status
Whether awake and oriented x 3
Measured: 90 days
Reintubation
Reintubation after extubation
Measured: 90 days
Mortality
Death
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start17 Mar 2025 (estimated)
- Primary completion8 Jun 2025 (estimated)
- Study completion8 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Ching, Oklahoma State University Center for Health Sciences
- Investigators
- Amber Hood, DFS, Study director, OSU CHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891248
- Sponsor's protocol ID
- 2024193
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Osteopathic Manipulative Medicine in Weaning Patients from the Ventilator
- ClinicalTrials.gov ID
- NCT06891248
- Acronym / sponsor ID
- 2024193
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- 8 Jun 2025 (estimated)
- Study completion
- 8 Jun 2025 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in these arms only receive conventional care |
| Osteopathic Manipulative Treatment | Experimental | Procedure: Osteopathic Manipulative TreatmentThe standard OMM treatment arm includes a 10-minute treatment time for 5 body regions with up to 3 providers working on the patient simultaneously. The OMM attending physician will be physically present and supervising the treatment, and may be participating in the treatment. The 5 body regions include Head, Neck, Thoracic, Ribs, and Abdominal/Diaphragm. The standard technique for the OMM arm includes OA decompression, screening and treating any cervical dysfunction, thoracic inlet myofascial release, rib raising, thoracic paraspinal inhibition, and abdominal diaphragm myofascial release. There is an opportunity for an additional 5 minutes of treatment time and additional regions if the lead physician determines it is appropriate based on clinical judgment. The additional 4 regions include Upper Extremity, Lower Extremity, Lumbar, Pelvis, and Sacrum. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentSee treatment arm | Procedure or surgery | Osteopathic Manipulative Treatment |
Primary outcome
Time on ventilator
Time frame: 90 days
Number of days that the patient is on the ventilator after inclusion in the study
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Respiratory Failure
Enrolling by invitation
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Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
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Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amber Hood, DFS study director
OSU CHS
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Respiratory Failure and Osteopathy in Diseases Classified Elsewhere, run by Oklahoma State University Center for Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie Ching, DO (540-818-2801, leslie.ching@okstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time on ventilator (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.