PMI Guide PS Setting in Pressure Support-ventilated Patients

PMI Guide PS Setting in Pressure Support-ventilated Patients - Prospective Multicenter Clinical RCT

Pressure support ventilation (PSV) is an assistant mechanical ventilation mode, that is widely implemented in mechanical ventilation treatment but there are no exact guidelines to guide PS setting. Traditional PS setting strategy (VT/PBW 6-8ml/kg and RR 20-30 breaths/min)has risks of excessive or insufficient assistance. Inspiratory muscle pressure index (PMI) is a noninvasive respiratory mechanical indicator and is available at the bedside. PMI was correlated with inspiratory effort and has the potential ability to predict low inspiratory effort and high inspiratory effort. The primary objective of this study is to investigate the clinical validity of a PMI-guided PS setting strategy. Specifically, the investigators aim to evaluate its impact on inspiratory effort as well as its potential for lung and diaphragm protection. Additionally, the investigators seek to assess the effect of this ventilation strategy on mechanical ventilation outcomes while evaluating the feasibility of our trial protocol.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Procedure: PS setting strategy in pressure-support ventilated patients

Detailed Description

Pressure support ventilation (PSV) is an assistant mechanical ventilation mode to provide synchronous inspiratory support for patients with spontaneous breathing and to efficiently reduce the workload imposed on the respiratory muscle. PSV is widely implemented in mechanical ventilation treatment but there are no exact guidelines to guide PS setting. Clinicians and respiratory therapists usually adjust ventilator parameters based on tidal volume/predicted body weight (VT/PBW, 6-8ml/kg) and current respiratory rate (RR, 20-30 breaths/min). This strategy has risks of excessive or insufficient assistance because the PS setting cannot be modulated dynamically based on the requirements of ventilated patients.

Inspiratory muscle pressure index (Pmus index, PMI) is defined as the difference between plateau pressure (Pplat) and airway peak pressure (Ppeak) during end-inspiratory occlusion (EIO). PMI is a noninvasive respiratory mechanical indicator and is available at the bedside like airway occlusion pressure (P0.1) because holding operations were integrated into the majority ventilator. Several studies showed PMI was correlated with inspiratory effort. Our previous study showed PMI has the potential ability to predict low inspiratory effort and high inspiratory effort, and the optimal cut-off PMI value was approximately 0 cmH2O and 2 cmH2O.

The primary objective of this study is to investigate the clinical validity of a PMI-guided PS setting strategy. Specifically, the investigators aim to evaluate its impact on inspiratory effort as well as its potential for lung and diaphragm protection. Additionally, the investigators seek to assess the effect of this ventilation strategy on mechanical ventilation outcomes while evaluating the feasibility of our trial protocol.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Jian-Xin Zhou, MD; Phone Number: 8610 59978019; Email: zhoujx.cn@icloud.com
      • Contact: Ran Gao; Phone Number: +8617647611107; Email: 1205961482@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients under PSV
• Predicted ventilated time of more than 48 hours.

Exclusion Criteria:

• Age less than 18 years old;
• Known pregnancy;
• BMI>35kg/m2;
• Brain-stem or cervical cord injury;
• Known or clinically suspected elevated intracranial pressure (ICP>18 mmHg);
• Nervus phrenicus or diaphragm injury;
• Broncho-pleural fistula;
• Chronic obstructive pulmonary disease (COPD);
• Pressure support ventilated time more than 48 hours before randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Patients randomized to the control arm need to continue to accept the traditional ventilation strategy which is VT/PBW (6-8ml/kg) and RR (20-30breaths/min) guide PS setting.
Experimental: Experimental arm; The initial PS level is set up based on VT/PBW (6-8ml/kg) and RR (20-30 breaths/min) when patients are enrolled in the experimental arm. The following steps need to be repeated every 2 hours for 48 hours. Step 1: 3 times short EIOs (2-3s) are performed. At least 1 minute between each occlusion. PMI is calculated as the mean value of 3 measured values. Step 2: Clarify whether PMI is in the target range (PMI 0-2cmH2O). If yes, keep this PS level. If not, implement step 3. Step 3: A downward or upward PS setting adjustment is performed at a 1cmH2O interval. Every PS level is maintained for 3-5 minutes. PMI is measured again and step 3 is repeated until the PMI target is reached. Step 4: supplemental adjustment: PS setting needs to be returned to the previous level if the patient presents the following signs: VT < 4 ml/Kg, RR > 35 breaths/min, respiratory acidosis, respiratory distress, VT > 10ml/Kg, Pplat > 30 cmH2O, respiratory alkalosis.	Procedure: PS setting strategy in pressure-support ventilated patients; Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of conditions in the range of normal inspiratory effort per patient	the time from the start of PSV mode to the successful weaning of the ventilated patients	up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of mechanical ventilation	the time from the start of mechanical ventilaion to the successful weaning of the patients	up to 28 days
Tracheostomy rate	the proportion of all subjects who underwent tracheostomy	up to 28 days
Reintubation rate	the proportion of all subjects who underwent reintubation	up to 28 days
Diaphragm thickness (Tdi)	using the Tdi to estimate the change of diaphragm function and activity during PSV	up to 28 days
Diaphragm thicken fraction (TFdi)	using the TFdi to estimate the change of diaphragm function and activity during PSV	up to 28 days
Diaphragm excursion (EXdi)	using the EXdi to estimate the change of diaphragm function and activity during PSV	up to 28 days
inspiratory muscle pressure (Pmus)	measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration	up to 28 days
esophageal pressure time product (PTPes)	measuring PTPes to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration	up to 28 days
number of participants with treatment-related adverse events as assessed by CTCAE v4.0	treatment-related adverse events including pneumothorax, circulatory instability, etc.	up to 28 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 1, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: pressure support ventilation; inspiratory effort; inspiratory muscle pressure index
• Other Study ID Numbers: KY2023-005-02

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
• product manufactured in and exported from the U.S.: No