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

NCT07375667 | Recruiting DMC

• 1 other identifier: 2025-K249-01
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 3

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.

Conditions

Mechanical Ventilation Pressure High; Ventilator-Associated Pneumonia (VAP); Respiratory Depression Neonatal

Keywords

Airway resistance

Outcome Measures

Primary Outcomes (1)

• The drop in airway viscous resistance before and after sputum suction

  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.

  the process of sputum aspiration(at most 30 minutes)

Secondary Outcomes (2)

• The number of participants with abnormal laboratory tests

  Laboratory testing time ( at least 30 minutes)

• Sputum bacterial culture

  3 days

Study Arms (2)

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.

Procedure: The dynamics of airway resistance; Diagnostic Test: conventional suctioning

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.

Interventions

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.

Airway resistance-guided sputum suction

conventional suctioning DIAGNOSTIC_TEST

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

Airway resistance-guided sputum suction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (3)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hong-lei Wu Nursing Department, MS

CONTACT

+8613862749927; wu_honglei@163.com

xuan Qian Nursing Department, MS

CONTACT

+8615162763676; 1660694568@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 29, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: January 29, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: From October 2025 until the end of the trial
• Access Criteria: Critical care researchers; all materials will be made available. Contact: Honglei Wu, e-mail: wu\ honglei@163.com

Locations

CN (3)