An interventional study of PS setting strategy in pressure-support ventilated patients in Mechanical Ventilation, sponsored by Capital Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Capital Medical University · Not applicable, Interventional, and Supportive care
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.
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.
Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).
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
Time frame: up to 48 hours
The duration of mechanical ventilation
the time from the start of mechanical ventilaion to the successful weaning of the patients
Time frame: up to 28 days
Tracheostomy rate
the proportion of all subjects who underwent tracheostomy
Time frame: up to 28 days
Reintubation rate
the proportion of all subjects who underwent reintubation
Time frame: up to 28 days
Diaphragm thickness (Tdi)
using the Tdi to estimate the change of diaphragm function and activity during PSV
Time frame: up to 28 days
Diaphragm thicken fraction (TFdi)
using the TFdi to estimate the change of diaphragm function and activity during PSV
Time frame: up to 28 days
Diaphragm excursion (EXdi)
using the EXdi to estimate the change of diaphragm function and activity during PSV
Time frame: up to 28 days
inspiratory muscle pressure (Pmus)
measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
Time frame: 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
Time frame: 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.
Time frame: up to 28 days
Plan to share: No
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