NCT05026463

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

August 17, 2021

Last Update Submit

December 26, 2021

Conditions

Mechanical Ventilation

Keywords

mechanical ventilationpressure supportinspiratory effortwork of breathinglung injury

Outcome Measures

Primary Outcomes (2)

  • Inspiratory effort

    Inspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.

    30 minutes

  • Work of breathing

    Work of breathing is measured by the Campbell diagram and pressure-time-product using esophageal pressure monitoring.

    30 minutes

Secondary Outcomes (7)

  • Respiratory system compliance (ml/cmH2O)

    30 minutes

  • Partial pressure of oxygen in arterial blood (mmHg)

    Partial pressure of oxygen in arterial blood

  • Partial pressure of carbon dioxide in arterial blood (mmHg)

    30 minutes

  • Respiratory rate (breaths/min)

    30 minutes

  • Tidal volume (ml)

    30 minutes

  • +2 more secondary outcomes

Study Arms (3)

Inspiratory support level with PMI equal to -2

EXPERIMENTAL

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

Procedure: Inspiratory support level

Inspiratory support level with PMI equal to 0

EXPERIMENTAL

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

Procedure: Inspiratory support level

Inspiratory support level with PMI equal to +2

EXPERIMENTAL

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

Procedure: Inspiratory support level

Interventions

Inspiratory support levelPROCEDURE

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

Inspiratory support level with PMI equal to +2Inspiratory support level with PMI equal to -2Inspiratory support level with PMI equal to 0

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

8610 59978019zhoujx.cn@icloud.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 30, 2021

Study Start

September 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)