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

NCT05950893 | Recruiting DMC

• 1 other identifier: KT2023-032-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Keywords

pressure support ventilation; inspiratory effort; inspiratory muscle pressure index

Outcome Measures

Primary Outcomes (1)

• Agreement of PMIvent and PMIref

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

  3 hours

Secondary Outcomes (2)

• Correlation of inspiratory effort and PMIvent

  3 hours

• The predicted value of PMIvent for low/high effort

  3 hours

Study Arms (1)

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

Interventions

pressure support level PROCEDURE

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jian-Xin Zhou: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

8610 59978019; zhoujx.cn@icloud.com

Ran Gao, MD

CONTACT

+8617647611107; 1205961482@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 18, 2023
• Study Start: March 25, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)