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

July 23, 2024 updated by: Jian-Xin Zhou

Inspiratory Contribution of Pressure Support-ventilated Patients in Different PMI Conditions - a Prospective Physiological Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adult acute respiratory failure patients undergoing mechanical ventilation were screened daily and enrolled 24 hours after switching to PSV mode.

Exclusion Criteria:

  1. age younger than 18 years old and more than 80 years old
  2. chronic occlusive pulmonary diseases
  3. known pregnancy and parturient
  4. gastric, esophageal, and diaphragm surgery
  5. barotrauma
  6. neuromuscular diseases
  7. intracranial hypertension and brain stem injury
  8. consciousness level decreased (SAS less than 3 scores)
  9. Anticipating withdrawal of life support and/or shift to palliation as the goal of care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.
Procedure: pressure support level tatrition
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The correlation between PMI and PTP ratio
Time Frame: 3 hours
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).
3 hours
The ability of PMI to detect different PTP ratios
Time Frame: 3 hours
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.
3 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tidal volume per predicted body weight (VT/PBW, ml/Kg)
Time Frame: 3 hours
We use the VT/PBW (ml/Kg) as lung-protective ventilation safety makers.
3 hours
Respiratory rate (RR, circle/min)
Time Frame: 3 hours
We use the RR (circle/min) as lung-protective ventilation safety makers.
3 hours
Transpulmonary driving pressure (DPlung, cmH2O)
Time Frame: 3 hours
We use the DPlung (cmH2O) as lung-protective ventilation safety makers.
3 hours
Respiratory driving pressure (DPrs, cmH2O)
Time Frame: 3 hours
We use the DPrs (cmH2O) as lung-protective ventilation safety makers.
3 hours
Respiratory muscle pressure (Pmus, cmH2O)
Time Frame: 3 hours
Our study chose Pmus (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.
3 hours
Esophageal pressure-time product (PTPes, cmH2O)
Time Frame: 3 hours
Our study chose PTPes (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jian-Xin Zhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2023-001-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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