Mechanical Ventilation Pressure HighNCT07375667
Dynamic Airway Resistance & ML: Guide Sputum Suction in Ventilated Patients
A study testing The dynamics of airway resistance and conventional suctioning in people with Mechanical Ventilation Pressure High and Ventilator-Associated Pneumonia (VAP), run by Affiliated Hospital of Nantong University at 3 sites in China.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilation Pressure High, Ventilator-Associated Pneumonia (VAP), Respiratory Depression Neonatal
- What is being tested?
- The dynamics of airway resistance and conventional suctioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 3 sitesChina
- Study dates
- 30 Oct 2025to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Acute Respiratory Distress Syndrome (ARDS)
- Clinical diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
- Clinical diagnosis of Severe pneumonia
Who cannot join
- Clinical diagnosis of multiple organ failure;
- Clinical diagnosis of multiple organ bleeding;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Zunzhu Li Director of the Nursing, MS, +8618612671363, 1981285238@qq.com
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
Yajun Li Director of the Nursing, MS, +8615955232235, liyajun1205@163.com
- Recruiting
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Mei-juan Lan Director of the Nursing Department, MS, +8613757119537, lmj3632@126.com
About this study
Official title: Mechanisms of Dynamic Airway Resistance Monitoring and Machine Learning for Assessing Pulmonary Inflammation and Guiding Sputum Suction in Mechanically 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.
Read the 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.
- Conditions
- Mechanical Ventilation Pressure High, Ventilator-Associated Pneumonia (VAP), Respiratory Depression Neonatal
- Being tested
- The dynamics of airway resistance, conventional suctioning
- Keywords
- Airway resistance
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The dynamics of airway resistanceProcedure or surgery
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 suctioningDiagnostic test
The timing for suctioning is determined based on clinical signs such as rhonchi and an elevated peak pressure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the process of sputum aspiration(at most 30 minutes)
Secondary outcomes (2)
The number of participants with abnormal laboratory tests
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.
Measured: Laboratory testing time ( at least 30 minutes)
Sputum bacterial culture
Sputum culture is performed to identify the source of infection and to diagnose VAP.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start30 Oct 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation Pressure HighStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375667
- Sponsor's protocol ID
- 2025-K249-01
- Status last verified
- Oct 2025
- First submitted
- 10 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Dynamic Airway Resistance Monitoring and Machine Learning for Assessing Pulmonary Inflammation and Guiding Sputum Suction in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT07375667
- Acronym / sponsor ID
- 2025-K249-01
- Conditions
- Mechanical Ventilation Pressure High, Ventilator-Associated Pneumonia (VAP), Respiratory Depression Neonatal
- Keywords
- Airway resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airway resistance-guided sputum suction | Experimental | Procedure: The dynamics of airway resistance, Diagnostic Test: conventional suctioningInvestigators will continuously monitor the airway viscous resistance of patients, and initiate suctioning when the airway viscous resistance increases by ≥6 cmH₂O. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Acute Respiratory Distress Syndrome (ARDS)
- Clinical diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
- Clinical diagnosis of Severe pneumonia
Key exclusion criteria (2 listed)
- Clinical diagnosis of multiple organ failure;
- Clinical diagnosis of multiple organ bleeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The dynamics of airway resistanceMonitoring 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. | Procedure or surgery | Airway resistance-guided sputum suction |
| conventional suctioningThe timing for suctioning is determined based on clinical signs such as rhonchi and an elevated peak pressure. | Diagnostic test | Airway resistance-guided sputum suction |
Primary outcome
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.
2 secondary outcomes
The number of participants with abnormal laboratory tests
Time frame: Laboratory testing time ( at least 30 minutes)
Sputum bacterial culture
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. All data
Related trials for Mechanical Ventilation Pressure High
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
Recruiting
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
Acute Hypoxemic Respiratory Failure
Recruiting
FCV vs VCV in Obstructive and Asthmatic Patients
Obstructive Pulmonary Disease, Mechanical Ventilation Pressure High
Recruiting
Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.
De Novo Hypoxemic Acute Respiratory Failure (hARF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The dynamics of airway resistance and conventional suctioning in people with Mechanical Ventilation Pressure High and Ventilator-Associated Pneumonia (VAP), run by Affiliated Hospital of Nantong University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong-lei Wu Nursing Department, MS (+8613862749927, wu_honglei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The drop in airway viscous resistance before and after sputum suction (time frame: the process of sputum aspiration(at most 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.