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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05026463
Enrollment
20
Registered
2021-08-30
Start date
2021-09-01
Completion date
2022-02-28
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation

Keywords

mechanical ventilation, pressure support, inspiratory effort, work of breathing, lung injury

Brief 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.

Interventions

PROCEDUREInspiratory support level

Inspiratory support is the pressure delivered by the ventilator during pressure support ventilation.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Inspiratory effort30 minutesInspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.
Work of breathing30 minutesWork of breathing is measured by the Campbell diagram and pressure-time-product using esophageal pressure monitoring.

Secondary

MeasureTime frameDescription
Partial pressure of carbon dioxide in arterial blood (mmHg)30 minutesPartial pressure of carbon dioxide in arterial blood is obtained by blood gas analysis.
Respiratory rate (breaths/min)30 minutesRespiratory rate calculation includes ineffective trigger.
Respiratory system compliance (ml/cmH2O)30 minutesRespiratory system compliance is calculated as the ratio between tidal volume and driving pressure.
Rapid shallow breathing index30 minutesRapid shallow breathing index is calculated as the ratio between respiratory rate and tidal volume.
The use of accessory respiratory muscle30 minutesThe use of accessory respiratory muscle is observed at the bedside.
Tidal volume (ml)30 minutesTidal volume is obtained by intergation of flow-time tracing.
Partial pressure of oxygen in arterial blood (mmHg)Partial pressure of oxygen in arterial bloodPartial pressure of oxygen in arterial blood is obtained by blood gas analysis.

Countries

China

Contacts

Primary ContactJian-Xin Zhou, MD
zhoujx.cn@icloud.com8610 59978019

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026