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The Clinical Feasibility and Validity of PMIvent to Access Inspiratory Effort During Pressure Support Ventilation

Primary Purpose

Mechanical Ventilation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pressure support level
Sponsored by
Jian-Xin Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mechanical Ventilation focused on measuring pressure support ventilation, inspiratory effort, inspiratory muscle pressure index

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult acute respiratory failure patients undergoing mechanical ventilation were screened daily and enrolled 24 hours after switching to PSV mode Exclusion Criteria: age younger than 18 years old or older than 85 years known pregnancy and parturient chronic occlusive pulmonary diseases gastric, esophageal injury barotrauma diaphragm dysfunction intracranial hypertension and brain stem injury consciousness level decreased (RASS less than -2 scores) Anticipating withdrawal of life support and/or shift to palliation as the goal of care.

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.

Outcomes

Primary Outcome Measures

Agreement of PMIvent and PMIref
The accuracy of PMIvent compared to PMIref was assessed by a Bland-Altman plot for each ventilator.

Secondary Outcome Measures

Correlation of inspiratory effort and PMIvent
The inspiratory effort is measured as the pressure generated by inspiratory muscles using esophageal pressure monitoring. This study selected Pmus and PTPes per minute as the reference for inspiratory effort.
The predicted value of PMIvent for low/high effort
The target range for "high" inspiratory effort was defined as Pmus > 10 cmH2O and PTPes per minute > 200 cmH2O·s·min-1, and the target range for "low" inspiratory effort was defined as Pmus < 5 cmH2O and PTPes per minute < 50 cmH2O·s·min-1.

Full Information

First Posted
July 1, 2023
Last Updated
July 15, 2023
Sponsor
Jian-Xin Zhou
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1. Study Identification

Unique Protocol Identification Number
NCT05950893
Brief Title
The Clinical Feasibility and Validity of PMIvent to Access Inspiratory Effort During Pressure Support Ventilation
Official Title
The Clinical Feasibility and Validity of Simple Measurement of Inspiratory Muscle Pressure Index (PMIvent) to Access Inspiratory Effort During Pressure Support Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2023 (Actual)
Primary Completion Date
July 25, 2023 (Anticipated)
Study Completion Date
July 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jian-Xin Zhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is critical to maintain a relatively normal inspiratory effort during pressure support ventilation (PSV), the support level should be adjusted to match the patient's inspiratory effort. The inspiratory muscle pressure index (PMI) can reflect the elastic work of the respiratory system at the end of inspiration and has a significant correlation with inspiratory effort, and it has the outgoing advantages of being non-invasive and easy to obtain. Previous studies on PMI were based on physiological research and experimental conditions (PMIref), which require special pressure monitoring devices and software to collect and measure airway pressure. If PMI is going to be used in clinical practice, it is necessary to find a simple measurement method of PMI to replace PMIref. Most ventilators have airway pressure monitoring and end-inspiratory holding functions, and PMI can be measured by freezing the ventilator screen (PMIvent). The overall aim of this study was to determine PMIvent's clinical feasibility and validity for accessing inspiratory effort during PSV.
Detailed Description
The intensity of effort the respiratory system produces after receiving respiratory center drive is referred to as inspiratory effort. It is critical to maintain a relatively normal inspiratory effort during assist mechanical ventilation. During pressure support ventilation (PSV), the support level should be adjusted to match the patient's inspiratory effort. The inspiratory muscle pressure index (PMI) is an indicator based on airway pressure (Paw), defined as the difference between plateau pressure (Pplat) and airway peak pressure (Ppeak). PMI can reflect the elastic work of the respiratory system at the end of inspiration and has a significant correlation with end-inspiratory muscle pressure (Pmus,ei) and esophageal pressure time product per breath (PTPes). Current studies have shown that PMI is an accurate indicator of inspiratory effort, and it has the outgoing advantages of being non-invasive and easy to obtain. Previous studies on PMI were based on physiological research and experimental conditions, which require special pressure monitoring devices and software to collect and measure airway pressure. In this investigation, the standard measurement of PMI (PMIref) was the difference between Pplat at one cardiac cycle (0.5-1.2s) following end-inspiratory occlusion (EIO) and Ppeak at EIO. This measurement method can avoid the interference of cardiac artifacts on Paw to the greatest extent. If PMI is going to be used in clinical practice, it is necessary to find a simple measurement method of PMI to replace PMIref. Most ventilators have airway pressure monitoring and end-inspiratory holding functions, and PMI can be measured by freezing the ventilator screen (PMIvent). When obtaining PMIvent, the operator could only select a relatively stationary Pplat by visual inspection, and the cardiac artifacts could not be avoided. Several additional issues need to be addressed when PMI is going to be used in clinical practice to monitor inspiratory effort in ventilated patients. Is PMI easy to obtain? Can PMIvent replace PMIref? What is the effect of different ventilators on PMIvent measurement? What is the relationship between PMIvent and inspiratory effort? Can PMIvent detect high/low effort? Therefore, the aims of this study were to explore the clinical acquisition rate of PMI, the agreement between PMIvent and PMIref, and the predicted value of PMIvent for inspiratory effort. The overall aim was to determine PMI's clinical feasibility and validity for accessing inspiratory effort during PSV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation
Keywords
pressure support ventilation, inspiratory effort, inspiratory muscle pressure index

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.
Intervention Type
Procedure
Intervention Name(s)
pressure support level
Intervention Description
Baseline ventilators were set by the principle of keeping VT/PBW at 6-8ml/kg and RR at 20-30 breaths/min and the decision of the responsible ICU physician. After then the fraction of inspired oxygen (FiO2), positive expiratory end pressure (PEEP), trigger sensitivity, and cycle-off criteria remain unchanged. Downward PS level titration was performed from 20 cmH2O to 2 cmH2O at a 2cm H2O interval. Every PS level was maintained for 20 minutes and then three end-inspiratory holdings (2-3seconds) and three end-expiratory holdings were performed. To avoid additional injury to the lung and diaphragm, the airway peak pressure (Ppeak) was limited to 30cmH2O.Inspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.
Primary Outcome Measure Information:
Title
Agreement of PMIvent and PMIref
Description
The accuracy of PMIvent compared to PMIref was assessed by a Bland-Altman plot for each ventilator.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Correlation of inspiratory effort and PMIvent
Description
The inspiratory effort is measured as the pressure generated by inspiratory muscles using esophageal pressure monitoring. This study selected Pmus and PTPes per minute as the reference for inspiratory effort.
Time Frame
3 hours
Title
The predicted value of PMIvent for low/high effort
Description
The target range for "high" inspiratory effort was defined as Pmus > 10 cmH2O and PTPes per minute > 200 cmH2O·s·min-1, and the target range for "low" inspiratory effort was defined as Pmus < 5 cmH2O and PTPes per minute < 50 cmH2O·s·min-1.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult acute respiratory failure patients undergoing mechanical ventilation were screened daily and enrolled 24 hours after switching to PSV mode Exclusion Criteria: age younger than 18 years old or older than 85 years known pregnancy and parturient chronic occlusive pulmonary diseases gastric, esophageal injury barotrauma diaphragm dysfunction intracranial hypertension and brain stem injury consciousness level decreased (RASS less than -2 scores) Anticipating withdrawal of life support and/or shift to palliation as the goal of care.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-Xin Zhou, MD
Phone
8610 59978019
Email
zhoujx.cn@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Gao, MD
Phone
+8617647611107
Email
1205961482@qq.com
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Gao, MD
Phone
+8617647611107
Email
1205961482@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Clinical Feasibility and Validity of PMIvent to Access Inspiratory Effort During Pressure Support Ventilation

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