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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Osteopathy in Diseases Classified Elsewhere
• Intervention / Treatment: Procedure: Osteopathic Manipulative Treatment

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leslie Ching, DO; Phone Number: 540-818-2801; Email: leslie.ching@okstate.edu
• Study Contact Backup: Name: Cameron Henderson, DO; Phone Number: 5804840849; Email: cameron.henderson@okstate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects in these arms only receive conventional care
Experimental: 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.	Procedure: Osteopathic Manipulative Treatment; See treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time on ventilator	Number of days that the patient is on the ventilator after inclusion in the study	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death	90 days
Ventilator associated measurement	VBG/ABG	90 days
Ventilator associated measurement	Negative inspiratory force (NIF)	90 days
Ventilator associated measurement	Rapid Shallow Breathing Index (RSBI)	90 days
Ventilator associated measurement	Airway occlusion pressure (P0.1)	90 days
Ventilator associated measurement	Fraction of inspired oxygen (FiO2)	90 days
Ventilator associated measurement	Positive end-expiratory pressure (PEEP)	90 days
Blood pressure	Blood pressure	90 days
Ventilator associated measurement	Spontaneous Tidal Volume (Spontaneous TV)	90 days
Mental status	Whether awake and oriented x 3	90 days
Reintubation	Reintubation after extubation	90 days

Collaborators and Investigators

• Sponsor: Oklahoma State University Center for Health Sciences
• Investigators: Study Director: Amber Hood, DFS, OSU CHS

Study record dates

Study Major Dates

• Study Start (Estimated): March 17, 2025
• Primary Completion (Estimated): June 8, 2025
• Study Completion (Estimated): June 8, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2024193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No