Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation

Mechanical Ventilation Clinical Trial

Official title:

Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026463
• Other study ID #: KY2021-012-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 2022

Study information

• Verified date: December 2021
• Source: Capital Medical University
• Contact: Jian-Xin Zhou, MD
• Phone: 8610 59978019
• Email: zhoujx.cn[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. Pressure muscle index (PMI) was introduced recently to evaluate the degree of spontaneous breathing effort. We hypothesize that PMI might be used as an indicator for over-assistance during PSV. In this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero PMI. Inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Mechanical ventilated patients within 48 hours after the transition from a controlled mode to PSV

Exclusion Criteria:

• History of neuromuscular disease

• History of diaphragm dysfunction and surgery

• History of esophageal, gastric or lung surgery

• Decreased level of consciousness

• Central respiratory drive dysfunction

• Considered withholding of life support

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Procedure:
• Inspiratory support level
Inspiratory support is the pressure delivered by the ventilator during pressure support ventilation.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	China-Japan Friendship 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	Inspiratory effort	Inspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.	30 minutes
Primary	Work of breathing	Work of breathing is measured by the Campbell diagram and pressure-time-product using esophageal pressure monitoring.	30 minutes
Secondary	Respiratory system compliance (ml/cmH2O)	Respiratory system compliance is calculated as the ratio between tidal volume and driving pressure.	30 minutes
Secondary	Partial pressure of oxygen in arterial blood (mmHg)	Partial pressure of oxygen in arterial blood is obtained by blood gas analysis.	Partial pressure of oxygen in arterial blood
Secondary	Partial pressure of carbon dioxide in arterial blood (mmHg)	Partial pressure of carbon dioxide in arterial blood is obtained by blood gas analysis.	30 minutes
Secondary	Respiratory rate (breaths/min)	Respiratory rate calculation includes ineffective trigger.	30 minutes
Secondary	Tidal volume (ml)	Tidal volume is obtained by intergation of flow-time tracing.	30 minutes
Secondary	Rapid shallow breathing index	Rapid shallow breathing index is calculated as the ratio between respiratory rate and tidal volume.	30 minutes
Secondary	The use of accessory respiratory muscle	The use of accessory respiratory muscle is observed at the bedside.	30 minutes