NCT05726513

Brief Summary

The goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure. The main question\[s\] it aims to answer are:

  • to evaluate which weaning trial is associated to a better regional ventilation distribution
  • to evaluate which weaning trial can be comparable to ventilation distribution after extubation Participants will undergo 3 clinically used weaning trials in a random order (cross-over trial). Researchers will compare the different steps to see if regional ventilation distribution is different among the different trial .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

January 13, 2023

Last Update Submit

February 2, 2023

Conditions

Acute Respiratory FailureMechanical Ventilation ComplicationVentilator-Induced Lung InjuryWeaning Failure

Keywords

Electrical Impedance tomographyWeaning trialAcute respiratory failureLung monitoring

Outcome Measures

Primary Outcomes (1)

  • Regional Ventilation distribution using Electrical Impedance Tomography

    The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials using Electrical Impedance Tomography and focusing on: * Regional ventilation distribution * Regional inhomogeneity * Regional compliance distribution * Center of Ventilation * Silent Spaces

    2 hours

Secondary Outcomes (1)

  • Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase

    48 hours

Study Arms (3)

Low support, high Positive end-expiratory pressure

OTHER

Low support, high Positive end-expiratory pressure

Diagnostic Test: Weaning trial - Low support, high Positive end-expiratory pressure

Low support, zero positive end-expiratory pressure

OTHER

Low support, zero positive end-expiratory pressure

Diagnostic Test: Weaning trial - Low support, zero positive end-expiratory pressure

Zero support, zero positive end-expiratory pressure

OTHER

Zero support, zero positive end-expiratory pressure

Diagnostic Test: Weaning trial - Zero support, zero positive end-expiratory pressure

Interventions

Weaning trial - Low support, high Positive end-expiratory pressureDIAGNOSTIC_TEST

The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 5 cmH2O

Low support, high Positive end-expiratory pressure
Weaning trial - Low support, zero positive end-expiratory pressureDIAGNOSTIC_TEST

The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 0 cmH2O

Low support, zero positive end-expiratory pressure
Weaning trial - Zero support, zero positive end-expiratory pressureDIAGNOSTIC_TEST

The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with 0 pressure support ventilation and a positive end expiratory pressure of 0 cmH2O

Zero support, zero positive end-expiratory pressure

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 and \< 70 years
  • Ready to be weaned from mechanical ventilation according to clinical criteria

You may not qualify if:

  • Age \< 18 years or \> 70 years
  • Presence of chest drains
  • Presence of pacemaker/impantable cardiac device;
  • diagnosis of Pneumothorax, or pneumomediastinum
  • Diagnois of neuromuscular diseases
  • Use of neuromuscular blockers in the 48 hours before screening;
  • Body mass index \> 35 kg/m2
  • Refusal to participate of the patient/next of kin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

RECRUITING

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 14, 2023

Study Start

February 15, 2023

Primary Completion

May 30, 2024

Study Completion

December 31, 2024

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)