Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100071, China
Location status: Recruiting
NCT Number: NCT05963737
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100071, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).
Time frame: up to 48 hours
the time from the start of PSV mode to the successful weaning of the ventilated patients
Time frame: up to 28 days
the time from the start of mechanical ventilaion to the successful weaning of the patients
Time frame: up to 28 days
the proportion of all subjects who underwent tracheostomy
Time frame: up to 28 days
the proportion of all subjects who underwent reintubation
Time frame: up to 28 days
using the Tdi to estimate the change of diaphragm function and activity during PSV
Time frame: up to 28 days
using the TFdi to estimate the change of diaphragm function and activity during PSV
Time frame: up to 28 days
using the EXdi to estimate the change of diaphragm function and activity during PSV
Time frame: up to 28 days
measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
Time frame: up to 28 days
measuring PTPes to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
Time frame: up to 28 days
treatment-related adverse events including pneumothorax, circulatory instability, etc.
Interested in participating?
Request InfoCapital Medical University
Other
PMI Guide PS Setting in Pressure Support-ventilated Patients - Prospective Multicenter Clinical RCT
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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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