PMI Guide PS Setting in Pressure Support-ventilated Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation

NCT05026463

Mechanical Ventilation

UNKNOWN NA

Pressure Muscle Index and Threshold of Over-assistance During Pressure Support Ventilation

NCT06494085

Acute Hypoxemic Respiratory Failure

RECRUITING

Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation

NCT06968793

Mechanical Ventilation Critical Care Inspiratory Effort

COMPLETED NA

Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

NCT02743624

Acute Mechanical Ventilatory Failure

COMPLETED NA

Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery

NCT07199881

Inspiratory Effort Mechanical Ventilation Major Abdominal Surgeries

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PS setting strategy in pressure-support ventilated patients

Intervention Type PROCEDURE

Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No