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Clinical Trials/NCT06093958
NCT06093958WithdrawnNot Applicable

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

HealthPartners Institute1 site in 1 countryStarted: December 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Lung compliance (mL/mmHg)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • •Age < 18 years old
  • •Pregnancy at the time of their inclusionary hospitalization
  • •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

Arms & Interventions

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.

Intervention: Manual loading of the chest wall (Diagnostic Test)

Outcomes

Primary Outcomes

Lung compliance (mL/mmHg)

Time Frame: 20 minutes total in measure duration.

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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