Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients

Sponsor
HealthPartners Institute (Other)
Overall Status
Withdrawn
CT.gov ID
NCT06093958
Collaborator
(none)
0
1
1
12
0

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Manual loading of the chest wall
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients: Incidence, Mechanism, and Novel Techniques for Detecting it at the Bedside
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Lung compliance (mL/mmHg) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regions Hospital Saint Paul Minnesota United States 55101

Sponsors and Collaborators

  • HealthPartners Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT06093958
Other Study ID Numbers:
  • A21-280
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2023