Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure-Targeted Assist/Control Ventilation

NCT07886918 | Not Yet Recruiting DMC

• 1 other identifier: IIT2026-033-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure-targeted assist/control ventilation (P-A/C) who retain spontaneous breathing. Participants initiate their own breaths, with assistance from the ventilator. Researchers will compare cPmus with reference inspiratory muscle pressure calculated using an esophageal balloon catheter, a thin pressure-measuring tube placed in the esophagus. The study will look at how closely the two methods are related and whether they give similar results. Participants will undergo simultaneous monitoring with cPmus and an esophageal balloon catheter during assisted P-A/C ventilation. Researchers will adjust positive end-expiratory pressure (PEEP) across four levels. The inspiratory pressure setting will remain unchanged. Researchers will record measurements from both methods at each PEEP level.

Conditions

Mechanical Ventilation; Critical Care

Keywords

Esophageal pressure; Mechanical ventilation; Inspiratory effort; Inspiratory muscle pressure

Outcome Measures

Primary Outcomes (4)

• Computed inspiratory muscle pressure (cPmus)

  Computed inspiratory muscle pressure (cPmus) will be measured.

  2 hours

• Inspiratory muscle pressure (Pmus)

  Inspiratory muscle pressure (Pmus) will be measured.

  2 hours

• Computed inspiratory muscle pressure-time product (cPTPmus)

  Computed inspiratory muscle pressure-time product (cPTPmus) will be measured.

  2 hours

• Inspiratory muscle pressure-time product (PTPmus)

  Inspiratory muscle pressure-time product (PTPmus) will be measured.

  2 hours

Secondary Outcomes (3)

• Occluded airway pressure at 100ms (P0.1)

  2 hours

• Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)

  2 hours

• Pressure muscle index (PMI)

  2 hours

Study Arms (4)

Positive end-expiratory pressure 11

EXPERIMENTAL

Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes.

Procedure: Positive end-expiratory pressure 11

Positive end-expiratory pressure 9

EXPERIMENTAL

Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes.

Procedure: Positive end-expiratory pressure 9

Positive end-expiratory pressure 7

EXPERIMENTAL

Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes.

Procedure: Positive end-expiratory pressure 7

Positive end-expiratory pressure 5

EXPERIMENTAL

Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes.

Procedure: Positive end-expiratory pressure 5

Interventions

Positive end-expiratory pressure 11 PROCEDURE

Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes.

Positive end-expiratory pressure 11

Positive end-expiratory pressure 9 PROCEDURE

Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes.

Positive end-expiratory pressure 9

Positive end-expiratory pressure 5 PROCEDURE

Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes.

Positive end-expiratory pressure 5

Positive end-expiratory pressure 7 PROCEDURE

Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes.

Positive end-expiratory pressure 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Receiving pressure-targeted assist/control ventilation.
• Retaining spontaneous breathing.
• Written informed consent provided by the participant or a legally authorized representative.

You may not qualify if:

• Contraindication to esophageal catheter placement, including uncontrolled coagulopathy, skull base fracture, upper gastrointestinal bleeding, tumor or surgery, neck surgery, or esophagogastric varices.
• Chest trauma, a postoperative state following lung surgery, an active pulmonary air leak (pneumothorax, pneumomediastinum, or bronchopleural fistula), or an indwelling chest drain.
• Neuromuscular disease, diaphragmatic dysfunction, or diaphragmatic surgery.
• Impaired central respiratory drive due to intracranial hypertension or brainstem injury.
• Hemodynamic instability, defined as mean arterial pressure \<60 mmHg, systolic blood pressure \>180 mmHg, heart rate \<40 or \>150 beats/min, or norepinephrine dose \>1 mcg/kg/min.
• Pregnancy or breastfeeding.
• A decision to withdraw life-sustaining treatment or provide palliative care.

Sponsors & Collaborators

• Jian-Xin Zhou: lead

Study Sites (1)

Beijing Shijitan Hospital

Beijing, China

Location

Study Officials

• Jian-Xin Zhou

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Xin Zhou, MD, PhD

CONTACT

8610 6392 6666; zhoujx.cn@icloud.com

Meng-Xue Hou, MD

CONTACT

himengxue@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Emergency and Critical Care Center

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)