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

NCT ID: NCT05026463

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Inspiratory support level with PMI equal to -2

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

Group Type EXPERIMENTAL

Inspiratory support level

Intervention Type PROCEDURE

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

Inspiratory support level with PMI equal to 0

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

Group Type EXPERIMENTAL

Inspiratory support level

Intervention Type PROCEDURE

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

Inspiratory support level with PMI equal to +2

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

Group Type EXPERIMENTAL

Inspiratory support level

Intervention Type PROCEDURE

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

Interventions

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Inspiratory support level

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jian-Xin Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian-Xin Zhou, MD

Role: CONTACT

8610 59978019

Facility Contacts

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De-Jing Song, BS

Role: primary

Yan-Lin Yang, MD

Role: primary

Other Identifiers

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KY2021-012-01

Identifier Type: -

Identifier Source: org_study_id

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