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

NCT ID: NCT06891248

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2025-06-08

Brief 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 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.

Conditions

Respiratory Failure; Osteopathy in Diseases Classified Elsewhere

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Subjects in these arms only receive conventional care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Osteopathic Manipulative Treatment

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.

Group Type: EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type: PROCEDURE

See treatment arm

Interventions

Osteopathic Manipulative Treatment

See treatment arm

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Acute respiratory failure (hypoxic, hypercapnic, or neuromuscular)

2. Not making satisfactory progress with weaning after being on the ventilator for more than 48 hours

3. Clinical stability for pressure support trial with ventilator to monitor ventilation progression

4. Pulmonology must be following the patient for standardized ventilator management approach and interventions as needed

5. Medical power of attorney (POA) or legally authorized representative (LAR) who is able to consent subject for trial enrollment and treatment

6. Patients who were not referred to the OMM service

Exclusion Criteria

1. Age less than 18 years old or more than 85 years old

2. BMI>60

3. 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)

4. Status epilepticus or EEG result pending

5. Post-arrest hypothermia protocol

6. Acute stroke

7. Acute rib fractures preventing the implementation of the treatment protocol

8. Acute spinal injury preventing the implementation of the treatment protocol

9. Recent head injury requiring close clinical monitoring

10. Ejection Fraction less than 15%

11. Pleural effusion requiring procedural intervention or inhibiting ventilator progress

12. Pericardial effusion or tamponade requiring procedural intervention or inhibiting ventilator progress

13. ACLS/cardiac arrest within the past 72 hours

14. Confirmed opioid overdose with positive urine drug screen and response to naloxone

15. Patients who were referred to the OMM service

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Leslie Ching

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amber Hood, DFS

Role: STUDY_DIRECTOR

OSU CHS

Central Contacts

Leslie Ching, DO

Role: CONTACT

leslie.ching@okstate.edu

540-818-2801

Cameron Henderson, DO

Role: CONTACT

cameron.henderson@okstate.edu

5804840849

Other Identifiers

2024193

Identifier Type: -

Identifier Source: org_study_id