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NCT Number: NCT05963737

PMI Guide PS Setting in Pressure Support-ventilated Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PS setting strategy in pressure-support ventilated patients

Procedure

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

Primary outcomes

  1. The proportion of conditions in the range of normal inspiratory effort per patient

    Time frame: up to 48 hours

    the time from the start of PSV mode to the successful weaning of the ventilated patients

Secondary outcomes

  1. The duration of mechanical ventilation

    Time frame: up to 28 days

    the time from the start of mechanical ventilaion to the successful weaning of the patients

  2. Tracheostomy rate

    Time frame: up to 28 days

    the proportion of all subjects who underwent tracheostomy

  3. Reintubation rate

    Time frame: up to 28 days

    the proportion of all subjects who underwent reintubation

  4. Diaphragm thickness (Tdi)

    Time frame: up to 28 days

    using the Tdi to estimate the change of diaphragm function and activity during PSV

  5. Diaphragm thicken fraction (TFdi)

    Time frame: up to 28 days

    using the TFdi to estimate the change of diaphragm function and activity during PSV

  6. Diaphragm excursion (EXdi)

    Time frame: up to 28 days

    using the EXdi to estimate the change of diaphragm function and activity during PSV

  7. inspiratory muscle pressure (Pmus)

    Time frame: up to 28 days

    measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration

  8. esophageal pressure time product (PTPes)

    Time frame: up to 28 days

    measuring PTPes to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration

  9. number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: up to 28 days

    treatment-related adverse events including pneumothorax, circulatory instability, etc.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2023
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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