PMI Guide PS Setting in Pressure Support-ventilated Patients

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963737
• Other study ID #: KY2023-005-02
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

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).

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 48 hours
Secondary	The duration of mechanical ventilation	the time from the start of mechanical ventilaion to the successful weaning of the patients	up to 28 days
Secondary	Tracheostomy rate	the proportion of all subjects who underwent tracheostomy	up to 28 days
Secondary	Reintubation rate	the proportion of all subjects who underwent reintubation	up to 28 days
Secondary	Diaphragm thickness (Tdi)	using the Tdi to estimate the change of diaphragm function and activity during PSV	up to 28 days
Secondary	Diaphragm thicken fraction (TFdi)	using the TFdi to estimate the change of diaphragm function and activity during PSV	up to 28 days
Secondary	Diaphragm excursion (EXdi)	using the EXdi to estimate the change of diaphragm function and activity during PSV	up to 28 days
Secondary	inspiratory muscle pressure (Pmus)	measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration	up to 28 days
Secondary	esophageal pressure time product (PTPes)	measuring PTPes to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration	up to 28 days
Secondary	number of participants with treatment-related adverse events as assessed by CTCAE v4.0	treatment-related adverse events including pneumothorax, circulatory instability, etc.	up to 28 days