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NCT Number: NCT07375667

Dynamic Airway Resistance & ML: Guide Sputum Suction in Ventilated Patients

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.

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Key information

Conditions

Mechanical Ventilation Pressure High Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Depression Neonatal Respiratory Tract Diseases Respiratory Tract Infections Ventilator-Associated Pneumonia (VAP)

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

The dynamics of airway resistance

Procedure

Monitoring the dynamic changes in airway resistance in patients can be used to reflect the progression of pulmonary inflammation and determine the optimal timing for suctioning.

conventional suctioning

Diagnostic Test

The timing for suctioning is determined based on clinical signs such as rhonchi and an elevated peak pressure.

Primary outcomes

  1. 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

  1. The number of participants with abnormal laboratory tests

    Time frame: Laboratory testing time ( at least 30 minutes)

    Venous blood testing was performed, including a complete blood count (white blood cell count [WBC], neutrophil percentage [NEUT%]), C-reactive protein (CRP), and procalcitonin (PCT) to assess the systemic inflammatory status.

  2. Sputum bacterial culture

    Time frame: 3 days

    Sputum culture is performed to identify the source of infection and to diagnose VAP.

Study contacts

Contact information is provided by the study sponsor or research team.

Hong-lei Wu Nursing Department, MS

CONTACT

[email protected]

+8613862749927

xuan Qian Nursing Department, MS

CONTACT

[email protected]

+8615162763676

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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