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

NCT06891248 | Not Yet Recruiting DMC

• 1 other identifier: 2024193
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time on ventilator

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

  90 days

Secondary Outcomes (11)

• Ventilator associated measurement

  90 days

• Ventilator associated measurement

  90 days

• Ventilator associated measurement

  90 days

• Ventilator associated measurement

  90 days

• Ventilator associated measurement

  90 days

Study Arms (2)

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.

Procedure: Osteopathic Manipulative Treatment

Interventions

Osteopathic Manipulative Treatment PROCEDURE

See treatment arm

Osteopathic Manipulative Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Amber Hood, DFS

  OSU CHS

  STUDY DIRECTOR

Central Study Contacts

Leslie Ching, DO

CONTACT

540-818-2801; leslie.ching@okstate.edu

Cameron Henderson, DO

CONTACT

5804840849; cameron.henderson@okstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: March 17, 2025
• Primary Completion: June 8, 2025
• Study Completion: June 8, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share