Postoperative pulmonary complications after major abdominal surgery in elderly patients and its association with patient-controlled analgesia.
Qiulan He, Zhenyi Lai, Senyi Peng...
https://pubmed.ncbi.nlm.nih.gov/39256677Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07199881
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
52 weeks
Total Duration
On this page
Sponsors
M
Mahidol University
Lead Sponsor
S
Siriraj Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating respiratory drive and inspiratory effort in adult patients admitted to the surgical ICU after major abdominal surgery who require mechanical ventilation. This observational study focuses on how patients respond to varying levels of pressure support ventilation (PSV) using non-invasive bedside measurements. The goal is to better understand patient adaptation to ventilatory support and identify patterns of under- and over-assistance that may affect outcomes. Participants will undergo a standardized stepwise protocol adjusting PSV at different pressure levels, including baseline, -6 cmH2O, -3 cmH2O, +3 cmH2O, +6 cmH2O, and then returning to baseline. Each adjustment is followed by a 2-minute stabilization period and repeated measurements of respiratory drive and inspiratory effort indices, such as airway occlusion pressure at 100 ms (P0.1), maximum negative occlusion pressure (Pocc), and pressure muscle index (PMI). These steps occur while patients remain on PSV for more than 48 hours in the ICU. During the study, researchers will monitor respiratory parameters at each PSV level, assessing how patients adapt. They will also track outcomes like duration of mechanical ventilation, need for reintubation or non-invasive ventilation, ICU length of stay, and hospital discharge disposition. Measurements are taken up to 3 days after enrollment, with follow-up extending through ICU and hospital stays, which may last from one to two months. This detailed monitoring aims to identify optimal PSV titration to improve clinical care.
CONDITIONS
Brief 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
You may qualify if you...
- Adult patients (≥18 years) admitted to the surgical ICU
- Recent major abdominal surgery involving intra-peritoneal operation without primary thoracic involvement
- Receiving invasive mechanical ventilation in pressure support ventilation (PSV) mode at enrollment
- On invasive mechanical ventilation for more than 48 hours
- Clinically stable with no planned extubation within 6 hours, defined by respiratory rate <35 breaths/min, SpO2 ≥90%, heart rate <140 bpm, no visible accessory muscle use, stable hemodynamics without vasopressor escalation, and ability to tolerate short-term PSV adjustments
You will not qualify if you...
- Known neuromuscular disease affecting respiratory muscle function
- Hemodynamic instability requiring escalation of vasopressor support
- Severe hypoxemic respiratory failure needing 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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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Up to 3 days after enrollment
Participants undergo a standardized stepwise pressure support ventilation (PSV) adjustment protocol with repeated measurements of respiratory drive and inspiratory effort indices.
1 protocol session with multiple PSV adjustments and measurements
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
N
Nattaya Raykateeraroj, MD
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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Published Research Related To This Trial
Postoperative pulmonary complications.
A Miskovic, A B Lumb
https://pubmed.ncbi.nlm.nih.gov/28186222Scoping review: The terminology used to describe major abdominal surgical procedures.
Alona Courtney, Jonathon Clymo, Yasmin Dorudi...
https://pubmed.ncbi.nlm.nih.gov/38342951Pressure support, patient effort and tidal volume: a conceptual model for a non linear interaction.
Mattia Docci, Giuseppe Foti, Laurent Brochard...
https://pubmed.ncbi.nlm.nih.gov/39506755Pressure support ventilation in intensive care patients receiving prolonged invasive ventilation.
Wisam Al-Bassam, Tapan Parikh, Ary Serpa Neto...
https://pubmed.ncbi.nlm.nih.gov/38046681Monitoring respiratory muscles effort during mechanical ventilation.
Julien P van Oosten, Evangelia Akoumianaki, Annemijn H Jonkman
https://pubmed.ncbi.nlm.nih.gov/39560150