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Inspiratory Contribution of Pressure Support-ventilated Patients in Different PMI Conditions

Primary Purpose

Mechanical Ventilation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pressure support level tatrition
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 - 80 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 and more than 80 years old chronic occlusive pulmonary diseases known pregnancy and parturient gastric, esophageal, and diaphragm surgery barotrauma neuromuscular diseases intracranial hypertension and brain stem injury consciousness level decreased (SAS less than 3 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

The correlation between PMI and PTP ratio
Regression was conducted by the linear mixed-effects model with patients managed as random effects. The correlation between PMI and PTP ratio was evaluated as the coefficient of determination (R2).
The ability of PMI to detect different PTP ratios
The ability of PMI to detect different inspiratory effort contribution proportions was assessed using the Area Under the Receiver-Operating-Characteristics Curve (AUROC). The optimal cut-off values were selected based on the Youden index.

Secondary Outcome Measures

Tidal volume per predicted body weight (VT/PBW, ml/Kg)
We use the VT/PBW (ml/Kg) as lung-protective ventilation safety makers.
Respiratory rate (RR, circle/min)
We use the RR (circle/min) as lung-protective ventilation safety makers.
Transpulmonary driving pressure (DPlung, cmH2O)
We use the DPlung (cmH2O) as lung-protective ventilation safety makers.
Respiratory driving pressure (DPrs, cmH2O)
We use the DPrs (cmH2O) as lung-protective ventilation safety makers.
Respiratory muscle pressure (Pmus, cmH2O)
Our study chose Pmus (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.
Esophageal pressure-time product (PTPes, cmH2O)
Our study chose PTPes (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.

Full Information

First Posted
July 1, 2023
Last Updated
July 24, 2023
Sponsor
Jian-Xin Zhou
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1. Study Identification

Unique Protocol Identification Number
NCT05970393
Brief Title
Inspiratory Contribution of Pressure Support-ventilated Patients in Different PMI Conditions
Official Title
Inspiratory Contribution of Pressure Support-ventilated Patients in Different PMI Conditions - a Prospective Physiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
August 7, 2023 (Anticipated)
Study Completion Date
August 7, 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
Pressure support ventilation (PSV) is an assisted mechanical ventilation mode that provides synchronous inspiratory support for patients with spontaneous breathing. PSV divides the work involved in producing ventilation between the ventilator and the patients. The patient inspiratory effort needs close monitoring to avoid inappropriate assistance and maintain favorable patient-ventilator interaction during PSV. Esophageal pressure (Pes)-derived parameters are regarded as golden indicators of inspiratory effort. Based on this precondition, the fraction of PTP generated by the patient during PSV (PTP ratio) can evaluate the inspiratory contribution proportion of ventilated patients with spontaneous breathing. Inspiratory muscle pressure index (PMI) was confirmed to be associated with inspiratory effort and can effectively predict low/high effort. The study tries to explore the relationship between PMI and PTP ratio and find the optimal cut-off value of PMI to predict different PTP ratios. Second, investigators want to verify the safety and validity of PMI-guided PS settings for pressure-support ventilated patients.
Detailed Description
Pressure support ventilation (PSV) is an assisted mechanical ventilation mode that provides synchronous inspiratory support for patients with spontaneous breathing. PSV divides the work involved in producing ventilation between the ventilator and the patients. The level of support should be adjusted to the patient's inspiratory effort for assisted ventilation to be successful. Despite PSV being commonly used in mechanical ventilation therapy, the PS setting is not precisely regulated. Clinicians and respiratory therapists typically use tidal volume/predicted body weight (VT/PBW, 6-8 ml/Kg) and respiratory rate (RR, 20-30 breaths/min) to modify ventilator settings. Because pressure support level is not dynamically modulated based on the inspiratory effort of ventilated patients in time, there is always the risk of excessive or insufficient assistance. Excessive assistance and low inspiratory effort may result in diaphragm disuse atrophy and ventilator-induced lung injury (VILI). Inadequate assistance and high inspiratory effort may result in diagram stretched injury and patient-inflicted lung injury (PSILI). Both situations cause strain and stress on the lung and diaphragm, which may influence the ICU clinical outcomes. The patient inspiratory effort needs close monitoring to avoid inappropriate assistance and maintain favorable patient-ventilator interaction during PSV. Esophageal pressure (Pes)-derived parameters are regarded as golden indicators of inspiratory effort, including respiratory muscle pressure (Pmus), esophageal pressure-time product (PTPes), etc. Based on this precondition, the fraction of PTP generated by the patient during PSV (PTP ratio) can evaluate the inspiratory contribution proportion of ventilated patients with spontaneous breathing. Pmus index (PMI) is defined as the change in airway pressure (Paw) during the end-inspiratory occlusion and represents the patient's current elastic workload. This variable was confirmed to be associated with inspiratory effort and can effectively predict low/high effort. More importantly, it is non-invasive and available at the bedside because respiratory hold operations are integrated into most ventilators. However, the relationship between PMI and the inspiratory contribution proportion of ventilated patients is not clear, and how to guide PS settings through PMI needs more research. Our study aims to explore the inspiratory contribution of pressure-support ventilated patients in different PMI conditions. In other words, investigators try to explore the relationship between PMI and PTP ratio and find the optimal cut-off value of PMI to predict different PTP ratios. Second, investigators want to verify the safety and validity of PMI-guided PS settings for pressure-support ventilated patients.

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 tatrition
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. Upward and downward PS level adjustments were performed from the baseline PS level at a 1cm 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. PMI mean value was measured and calculated at every PS level. To avoid additional injury to the lung and diaphragm, the airway peak pressure (Ppeak) was limited to 30cmH2O, and titrating PS was stopped until PMI was less than -1cmH2O and more than 3cmH2O.The inspiratory effort is measured as the pressure generated by inspiratory muscles using esophageal pressure monitoring.
Primary Outcome Measure Information:
Title
The correlation between PMI and PTP ratio
Description
Regression was conducted by the linear mixed-effects model with patients managed as random effects. The correlation between PMI and PTP ratio was evaluated as the coefficient of determination (R2).
Time Frame
3 hours
Title
The ability of PMI to detect different PTP ratios
Description
The ability of PMI to detect different inspiratory effort contribution proportions was assessed using the Area Under the Receiver-Operating-Characteristics Curve (AUROC). The optimal cut-off values were selected based on the Youden index.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Tidal volume per predicted body weight (VT/PBW, ml/Kg)
Description
We use the VT/PBW (ml/Kg) as lung-protective ventilation safety makers.
Time Frame
3 hours
Title
Respiratory rate (RR, circle/min)
Description
We use the RR (circle/min) as lung-protective ventilation safety makers.
Time Frame
3 hours
Title
Transpulmonary driving pressure (DPlung, cmH2O)
Description
We use the DPlung (cmH2O) as lung-protective ventilation safety makers.
Time Frame
3 hours
Title
Respiratory driving pressure (DPrs, cmH2O)
Description
We use the DPrs (cmH2O) as lung-protective ventilation safety makers.
Time Frame
3 hours
Title
Respiratory muscle pressure (Pmus, cmH2O)
Description
Our study chose Pmus (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.
Time Frame
3 hours
Title
Esophageal pressure-time product (PTPes, cmH2O)
Description
Our study chose PTPes (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 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 and more than 80 years old chronic occlusive pulmonary diseases known pregnancy and parturient gastric, esophageal, and diaphragm surgery barotrauma neuromuscular diseases intracranial hypertension and brain stem injury consciousness level decreased (SAS less than 3 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 63926888
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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Inspiratory Contribution of Pressure Support-ventilated Patients in Different PMI Conditions

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