Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07199881

Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery

Led by Mahidol University · Updated on 2025-11-18

40

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

Sponsors

M

Mahidol University

Lead Sponsor

S

Siriraj Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This physiological observational study will assess respiratory drive and inspiratory effort across varying levels of pressure support ventilation (PSV) in adult surgical ICU (SICU) patients after major abdominal surgery. By using non-invasive bedside indices (airway occlusion pressure at 100 ms after the onset of inspiration \[P0.1\], maximum negative occlusion pressure \[Pocc\], and pressure muscle index \[PMI\]), we aim to quantify how patients adapt to changes in ventilatory support and determine patterns of under- and over-assistance. Findings may inform optimal titration of PSV to reduce complications and improve clinical outcomes.

CONDITIONS

Official Title

Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (≥18 years) admitted to the surgical ICU
  • Recent major abdominal surgery requiring postoperative ICU care
  • Receiving invasive mechanical ventilation in pressure support ventilation (PSV) mode at enrollment
  • Duration of invasive mechanical ventilation greater than 48 hours
  • Clinically stable with no plan for extubation within 6 hours, defined by respiratory rate <35 breaths/min, SpO2 ≥90%, heart rate <140 bpm, no visible accessory muscle use, hemodynamically stable without vasopressor escalation during past hour
  • Able to tolerate short-term PSV adjustments as per protocol
Not Eligible

You will not qualify if you...

  • Known neuromuscular disease affecting respiratory muscle function
  • Hemodynamic instability requiring escalation of vasopressor support
  • Severe hypoxemic respiratory failure requiring PEEP >10 cmH2O or FiO2 >60%
  • Deep sedation (Richmond Agitation-Sedation Scale score < -3) or ongoing neuromuscular blockade
  • History of chronic obstructive pulmonary disease (COPD) or other obstructive lung disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkoknoi, Thailand, 10700

Actively Recruiting

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Research Team

N

Nuanprae Kitisin, MD

CONTACT

N

Nattaya Raykateeraroj, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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