Inspiratory Contribution of Pressure Support-ventilated Patients in Different PMI Conditions

NCT05970393 | Completed DMC

• 1 other identifier: KY2023-001-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Pressure support ventilation (PSV) is an assisted mechanical ventilation mode that provides synchronous inspiratory support for patients with spontaneous breathing. PSV divides the work involved in producing ventilation between the ventilator and the patients. The patient inspiratory effort needs close monitoring to avoid inappropriate assistance and maintain favorable patient-ventilator interaction during PSV. Esophageal pressure (Pes)-derived parameters are regarded as golden indicators of inspiratory effort. Based on this precondition, the fraction of PTP generated by the patient during PSV (PTP ratio) can evaluate the inspiratory contribution proportion of ventilated patients with spontaneous breathing. Inspiratory muscle pressure index (PMI) was confirmed to be associated with inspiratory effort and can effectively predict low/high effort. The study tries to explore the relationship between PMI and PTP ratio and find the optimal cut-off value of PMI to predict different PTP ratios. Second, investigators want to verify the safety and validity of PMI-guided PS settings for pressure-support ventilated patients.

Conditions

Mechanical Ventilation

Keywords

pressure support ventilation; inspiratory effort; inspiratory muscle pressure index

Outcome Measures

Primary Outcomes (2)

• The correlation between PMI and PTP ratio

  Regression was conducted by the linear mixed-effects model with patients managed as random effects. The correlation between PMI and PTP ratio was evaluated as the coefficient of determination (R2).

  3 hours

• The ability of PMI to detect different PTP ratios

  The ability of PMI to detect different inspiratory effort contribution proportions was assessed using the Area Under the Receiver-Operating-Characteristics Curve (AUROC). The optimal cut-off values were selected based on the Youden index.

  3 hours

Secondary Outcomes (6)

• Tidal volume per predicted body weight (VT/PBW, ml/Kg)

  3 hours

• Respiratory rate (RR, circle/min)

  3 hours

• Transpulmonary driving pressure (DPlung, cmH2O)

  3 hours

• Respiratory driving pressure (DPrs, cmH2O)

  3 hours

• Respiratory muscle pressure (Pmus, cmH2O)

  3 hours

Study Arms (1)

Experimental

EXPERIMENTAL

PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.

Procedure: pressure support level tatrition

Interventions

pressure support level tatrition PROCEDURE

Baseline ventilators were set by the principle of keeping VT/PBW at 6-8ml/kg and RR at 20-30 breaths/min and the decision of the responsible ICU physician. After then the fraction of inspired oxygen (FiO2), positive expiratory end pressure (PEEP), trigger sensitivity, and cycle-off criteria remain unchanged. Upward and downward PS level adjustments were performed from the baseline PS level at a 1cm H2O interval. Every PS level was maintained for 20 minutes and then three end-inspiratory holdings (2-3seconds) and three end-expiratory holdings were performed. PMI mean value was measured and calculated at every PS level. To avoid additional injury to the lung and diaphragm, the airway peak pressure (Ppeak) was limited to 30cmH2O, and titrating PS was stopped until PMI was less than -1cmH2O and more than 3cmH2O.The inspiratory effort is measured as the pressure generated by inspiratory muscles using esophageal pressure monitoring.

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult acute respiratory failure patients undergoing mechanical ventilation were screened daily and enrolled 24 hours after switching to PSV mode.

You may not qualify if:

• age younger than 18 years old and more than 80 years old
• chronic occlusive pulmonary diseases
• known pregnancy and parturient
• gastric, esophageal, and diaphragm surgery
• barotrauma
• neuromuscular diseases
• intracranial hypertension and brain stem injury
• consciousness level decreased (SAS less than 3 scores)
• Anticipating withdrawal of life support and/or shift to palliation as the goal of care.

Sponsors & Collaborators

• Jian-Xin Zhou: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

Related Publications (1)

• Gao R, Zhou JX, Yang YL, Xu SS, Zhou YM, Zhang L, Miao MY. Use of pressure muscle index to predict the contribution of patient's inspiratory effort during pressure support ventilation: a prospective physiological study. Front Med (Lausanne). 2024 Apr 26;11:1390878. doi: 10.3389/fmed.2024.1390878. eCollection 2024.

  PMID: 38737762 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: August 1, 2023
• Study Start: February 7, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)