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Clinical Trials/NCT07375667
NCT07375667RecruitingNot Applicable

Mechanisms of Dynamic Airway Resistance Monitoring and Machine Learning for Assessing Pulmonary Inflammation and Guiding Sputum Suction in Mechanically Ventilated Patients

Affiliated Hospital of Nantong University3 sites in 1 country258 target enrollmentStarted: October 30, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
258
Locations
3
Primary Endpoint
The drop in airway viscous resistance before and after sputum suction

Study Overview

Brief Summary

Research has shown that timely suctioning not only improves survival rates but also enhances the quality of life in ventilator-dependent patients. However, clinical judgment on the optimal timing for suctioning currently relies primarily on physician experience, lacking scientific evidence [10]. Airway viscous resistance reflects the frictional resistance encountered by gas flow within the airways and is closely associated with airway patency. When airway secretions increase, viscous resistance undergoes dynamic changes. Therefore, analyzing these dynamic variations in viscous resistance derived from ventilator waveforms to determine the optimal suctioning timing and assess its clinical impact on the progression of pulmonary inflammation holds significant scientific value and offers new insights and methodologies for clinical practice.

Detailed Description

To validate the clinical feasibility and reliability of airway viscous resistance monitoring, explore the temporal correlation between inflammatory biomarkers and changes in airway viscous resistance, establish a reference threshold system for special populations, and provide experimental evidence for determining the optimal suctioning timing.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinical diagnosis of Acute Respiratory Distress Syndrome (ARDS)
  • Clinical diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
  • Clinical diagnosis of Severe pneumonia

Exclusion Criteria

  • Clinical diagnosis of multiple organ failure;
  • Clinical diagnosis of multiple organ bleeding;

Arms & Interventions

Airway resistance-guided sputum suction

Experimental

Investigators will continuously monitor the airway viscous resistance of patients, and initiate suctioning when the airway viscous resistance increases by ≥6 cmH₂O.

Intervention: The dynamics of airway resistance (Procedure)

Airway resistance-guided sputum suction

Experimental

Investigators will continuously monitor the airway viscous resistance of patients, and initiate suctioning when the airway viscous resistance increases by ≥6 cmH₂O.

Intervention: conventional suctioning (Diagnostic Test)

conventional suctioning

No Intervention

In the control group, the decision to suction was made based on conventional clinical signs, including rhonchi and a rise in peak pressure.

Outcomes

Primary Outcomes

The drop in airway viscous resistance before and after sputum suction

Time Frame: the process of sputum aspiration(at most 30 minutes)

Airway viscous resistance drop (AVRD) is the primary efficacy endpoint of this study. It is defined as the difference in airway viscous resistance measured immediately before and after suctioning. Procedure: Record the ventilator-displayed viscous resistance value pre-suction; immediately after the maneuver, re-measure both viscous resistance and peak airway pressure with a high-precision pressure-time sensor. Calculation: The within-patient difference (pre minus post) is the AVRD. In a pilot study of nine patients, AVRD averaged 6.889 ± 3.551 cmH₂O, significantly larger than the concurrent peak-pressure drop (1.556 ± 1.740 cmH₂O), indicating that AVRD is more sensitive to the effect of suction on airway secretions. Clinical implication: AVRD can serve as a quantitative criterion for determining the optimal timing of endotracheal suction.

Secondary Outcomes

  • The number of participants with abnormal laboratory tests(Laboratory testing time ( at least 30 minutes))
  • Sputum bacterial culture(3 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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