Back to resultsEvaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation (WEAN-EIT)
Primary Purpose
Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Weaning trial - Low support, high Positive end-expiratory pressure
Weaning trial - Low support, zero positive end-expiratory pressure
Weaning trial - Zero support, zero positive end-expiratory pressure
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Respiratory Failure focused on measuring Electrical Impedance tomography, Weaning trial, Acute respiratory failure, Lung monitoring
Eligibility Criteria
Inclusion Criteria: Age > 18 and < 70 years Ready to be weaned from mechanical ventilation according to clinical criteria Exclusion Criteria: 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
Sites / Locations
- Azienda Ospedaliero Universitaria Sant'AnnaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Low support, high Positive end-expiratory pressure
Low support, zero positive end-expiratory pressure
Zero support, zero positive end-expiratory pressure
Arm Description
Low support, high Positive end-expiratory pressure
Low support, zero positive end-expiratory pressure
Zero support, zero positive end-expiratory pressure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase
The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials and the post-extubation phase using Electrical Impedance Tomography and focusing on:
Regional ventilation distribution
Regional inhomogeneity
Regional compliance distribution
Center of Ventilation
Silent Spaces
Full Information
NCT ID
NCT05726513
First Posted
January 13, 2023
Last Updated
February 2, 2023
Sponsor
Università degli Studi di Ferrara
Collaborators
University of Milan
1. Study Identification
Unique Protocol Identification Number
NCT05726513
Brief Title
Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation
Acronym
WEAN-EIT
Official Title
Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Ferrara
Collaborators
University of Milan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury, Weaning Failure
Keywords
Electrical Impedance tomography, Weaning trial, Acute respiratory failure, Lung monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low support, high Positive end-expiratory pressure
Arm Type
Other
Arm Description
Low support, high Positive end-expiratory pressure
Arm Title
Low support, zero positive end-expiratory pressure
Arm Type
Other
Arm Description
Low support, zero positive end-expiratory pressure
Arm Title
Zero support, zero positive end-expiratory pressure
Arm Type
Other
Arm Description
Zero support, zero positive end-expiratory pressure
Intervention Type
Diagnostic Test
Intervention Name(s)
Weaning trial - Low support, high Positive end-expiratory pressure
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Weaning trial - Low support, zero positive end-expiratory pressure
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Weaning trial - Zero support, zero positive end-expiratory pressure
Intervention Description
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
Primary Outcome Measure Information:
Title
Regional Ventilation distribution using Electrical Impedance Tomography
Description
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
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase
Description
The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials and the post-extubation phase using Electrical Impedance Tomography and focusing on:
Regional ventilation distribution
Regional inhomogeneity
Regional compliance distribution
Center of Ventilation
Silent Spaces
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 and < 70 years
Ready to be weaned from mechanical ventilation according to clinical criteria
Exclusion Criteria:
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
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Sant'Anna
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savino Spadaro, MD
Phone
+390532239780
Email
savinospadaro@gmail.com
First Name & Middle Initial & Last Name & Degree
Gaetano Scaramuzzo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation
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