PMI Guide PS Setting in Pressure Support-ventilated Patients
Study Details
Study Description
Brief Summary
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 aim of this study is to explore whether the PMI-guided PS setting strategy can shorten the duration of assisted mechanical ventilation compared with the traditional PS setting strategy. Secondarily, the investigators aim to explore the effects of this ventilation strategy on other mechanical ventilation treatment outcomes, and whether it results in better protection of the lung and diaphragm.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 aim of this study is to explore whether the PMI-guided PS setting strategy can shorten the duration of assisted mechanical ventilation compared with the traditional PS setting strategy. Secondarily, the investigators aim to explore the effects of this ventilation strategy on other mechanical ventilation treatment outcomes, and whether it results in better protection of the lung and diaphragm.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 once per 12 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).
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| 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. |
Outcome Measures
Primary Outcome Measures
- The duration of pressure-supported mechanical ventilation [up to 28 days]
the time from the start of PSV mode to the successful weaning of the ventilated patients
Secondary Outcome Measures
- The duration of mechanical ventilation [up to 28 days]
the time from the start of mechanical ventilaion to the successful weaning of the patients
- Tracheostomy rate [up to 28 days]
the proportion of all subjects who underwent tracheostomy
- Reintubation rate [up to 28 days]
the proportion of all subjects who underwent reintubation
- Diaphragm thickness (Tdi) [up to 28 days]
using the Tdi to estimate the change of diaphragm function and activity during PSV
- Diaphragm thicken fraction (TFdi) [up to 28 days]
using the TFdi to estimate the change of diaphragm function and activity during PSV
- Diaphragm excursion (EXdi) [up to 28 days]
using the EXdi to estimate the change of diaphragm function and activity during PSV
- inspiratory muscle pressure (Pmus) [up to 28 days]
measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
- esophageal pressure time product (PTPes) [up to 28 days]
measuring PTPes to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
- number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [up to 28 days]
treatment-related adverse events including pneumothorax, circulatory instability, etc.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients under PSV
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Predicted ventilated time of more than 48 hours.
Exclusion Criteria:
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Age less than 18 years old;
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Known pregnancy;
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BMI>35kg/m2;
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Brain-stem or cervical cord injury;
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Known or clinically suspected elevated intracranial pressure (ICP>18 mmHg);
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Nervus phrenicus or diaphragm injury;
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Broncho-pleural fistula;
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Chronic obstructive pulmonary disease (COPD);
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Pressure support ventilated time more than 48 hours before randomization.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tiantan Hospital | Beijing | Beijing | China | 100071 |
Sponsors and Collaborators
- Capital Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY2023-005-02