- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375667
Dynamic Airway Resistance & ML: Guide Sputum Suction in Ventilated Patients
Mechanisms of Dynamic Airway Resistance Monitoring and Machine Learning for Assessing Pulmonary Inflammation and Guiding Sputum Suction in Mechanically Ventilated Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hong-lei Wu Nursing Department, MS
- Phone Number: +8613862749927
- Email: wu_honglei@163.com
Study Contact Backup
- Name: xuan Qian Nursing Department, MS
- Phone Number: +8615162763676
- Email: 1660694568@qq.com
Study Locations
-
-
Anhui
-
Bengbu, Anhui, China, 233000
- Recruiting
- The First Affiliated Hospital of Bengbu Medical University
-
Contact:
- Yajun Li Director of the Nursing, MS
- Phone Number: +8615955232235
- Email: liyajun1205@163.com
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100000
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Zunzhu Li Director of the Nursing, MS
- Phone Number: +8618612671363
- Email: 1981285238@qq.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Recruiting
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
Contact:
- Mei-juan Lan Director of the Nursing Department, MS
- Phone Number: +8613757119537
- Email: lmj3632@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Airway resistance-guided sputum suction
Investigators will continuously monitor the airway viscous resistance of patients, and initiate suctioning when the airway viscous resistance increases by ≥6 cmH₂O.
|
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.
The timing for suctioning is determined based on clinical signs such as rhonchi and an elevated peak pressure.
|
|
No Intervention: conventional suctioning
In the control group, the decision to suction was made based on conventional clinical signs, including rhonchi and a rise in peak pressure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
the process of sputum aspiration(at most 30 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Laboratory testing time ( at least 30 minutes)
|
|
Sputum bacterial culture
Time Frame: 3 days
|
Sputum culture is performed to identify the source of infection and to diagnose VAP.
|
3 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-K249-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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