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

• Sponsor: Capital Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05026463
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 5
• Patients Per Site: 10
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation	Procedure: Inspiratory support level	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Inspiratory support level; Inspiratory support is the pressure delivered by the ventilator during pressure support ventilation.
Experimental: 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.	Procedure: Inspiratory support level; Inspiratory support is the pressure delivered by the ventilator during pressure support ventilation.
Experimental: 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.	Procedure: Inspiratory support level; Inspiratory support is the pressure delivered by the ventilator during pressure support ventilation.

Outcome Measures

Primary Outcome Measures

1. Inspiratory effort [30 minutes]

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

2. Work of breathing [30 minutes]

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

Secondary Outcome Measures

1. Respiratory system compliance (ml/cmH2O) [30 minutes]

   Respiratory system compliance is calculated as the ratio between tidal volume and driving pressure.

2. Partial pressure of oxygen in arterial blood (mmHg) [Partial pressure of oxygen in arterial blood]

   Partial pressure of oxygen in arterial blood is obtained by blood gas analysis.

3. Partial pressure of carbon dioxide in arterial blood (mmHg) [30 minutes]

   Partial pressure of carbon dioxide in arterial blood is obtained by blood gas analysis.

4. Respiratory rate (breaths/min) [30 minutes]

   Respiratory rate calculation includes ineffective trigger.

5. Tidal volume (ml) [30 minutes]

   Tidal volume is obtained by intergation of flow-time tracing.

6. Rapid shallow breathing index [30 minutes]

   Rapid shallow breathing index is calculated as the ratio between respiratory rate and tidal volume.

7. The use of accessory respiratory muscle [30 minutes]

   The use of accessory respiratory muscle is observed at the bedside.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China-Japan Friendship Hospital	Beijing	Beijing	China	100029
2	Beijing Tiantan Hospital	Beijing	Beijing	China	100070

Sponsors and Collaborators

• Capital Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
• ClinicalTrials.gov Identifier: NCT05026463
• Other Study ID Numbers: KY2021-012-01
• First Posted: Aug 30, 2021
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jian-Xin Zhou, Professor, Capital Medical University: mechanical ventilation; pressure support; inspiratory effort; work of breathing; lung injury

Study Results

No Results Posted as of Jan 11, 2022