Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients

Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients: Incidence, Mechanism, and Novel Techniques for Detecting it at the Bedside

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; ARDS; Ventilator-Induced Lung Injury; Mechanical Ventilation Pressure High
• Intervention / Treatment: Diagnostic test: Manual loading of the chest wall

Detailed Description

Mechanical ventilation can be a life-saving intervention for patients with respiratory failure, but the acutely injured lung is vulnerable to further damage if positive pressure ventilation is not employed judiciously. "Lung protective ventilation" encompasses a group of practices intended to minimize ventilator-induced lung injury (VILI) and includes the delivery of low tidal volumes (to minimize dynamic lung strain) and the prevention of injuriously high airway pressures (to minimize lung stress). The prone position, which compresses (or "loads") the chest wall, more evenly distributes volume and pressure, mitigates the damaging effects of stress/strain, and improves clinical outcomes in patients with severe respiratory failure from adult respiratory distress syndrome (ARDS).

Chest wall loading would not be expected to produce these beneficial effects in the supine position-quite the opposite; it usually results in net volume loss and higher airway pressures in response to an unchanging tidal volume. A paradoxical response to chest wall loading, leading to decreased airway pressures, however, was recently reported in a group of patients with advanced lung disease secondary to COVID-19. In this cohort, a paradoxical decrease in airway pressures was elicited during a brief period of manual compression of the abdomen.

This maneuver, which is non-invasive, free of cost, and gives real-time information, may have important diagnostic (and potentially therapeutic) implications for ventilator management in patients with respiratory failure.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria: Non-surgical patients admitted to the ICU at Regions Hospital (St. Paul, MN) or Methodist Hospital (St. Louis Park, MN), receiving mechanical ventilation for any reason, and breathe passively during mechanical ventilation

Exclusion Criteria:

1. Age < 18 years old
2. Pregnancy at the time of their inclusionary hospitalization
3. Recent (< 30 days) abdominal or chest wall surgery (including spine)
4. Recent (< 30 days) abdominal or chest wall trauma (including spine)
5. Traumatic brain injury, intracranial bleed, or recent neurologic surgery
6. Family member or representative not available to provide informed consent
7. Not passive while receiving mechanical ventilation support
8. Hemodynamic instability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chest wall loading; 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; The chest wall will be loaded by either compression of the abdominal wall, compression of the lumbar spine, or compression of the sternum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: John Selickman, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: A21-280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study did not enroll any participants so there is no IPD to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes