Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients

NCT06093958 | Withdrawn FDA Device

• 1 other identifier: A21-280
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of our study are to: 1) determine the incidence of paradoxical response to chest wall loading in mechanically ventilated patients; 2) identify sub-populations in which it is most likely to occur (e.g., severe ARDS); and 3) standard the bedside procedure for demonstrating this physiology.

Conditions

ARDS; COVID-19; Mechanical Ventilation Pressure High; Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• Lung compliance (mL/mmHg)

  Does lung compliance improve (ie, increase) with an intervention (chest wall loading) that decreases chest wall compliance/reduces lung volume.

  20 minutes total in measure duration.

Study Arms (1)

Chest wall loading

EXPERIMENTAL

All patients who are receiving mechanical ventilation and are passive on the ventilator will have chest wall loading performed to identify whether there is a paradoxical decrease in lung compliance.

Diagnostic Test: Manual loading of the chest wall

Interventions

Manual loading of the chest wall DIAGNOSTIC_TEST

The chest wall will be loaded by either compression of the abdominal wall, compression of the lumbar spine, or compression of the sternum.

Chest wall loading

Eligibility Criteria

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

You may not qualify if:

• Age \< 18 years old
• Recent (\< 30 days) abdominal or chest wall surgery (including spine)
• Recent (\< 30 days) abdominal or chest wall trauma (including spine)
• Traumatic brain injury, intracranial bleed, or recent neurologic surgery
• Family member or representative not available to provide informed consent
• Not passive while receiving mechanical ventilation support
• Hemodynamic instability

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

COVID-19; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Injury

Study Officials

• John Selickman, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: October 23, 2023
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 7, 2024

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)