Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients

NCT ID: NCT06093958

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-12-01

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Manual loading of the chest wall

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Selickman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

A21-280

Identifier Type: -

Identifier Source: org_study_id