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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05026463
Other study ID # KY2021-012-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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