Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06093958
• Other study ID #: A21-280
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2021
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.