Mechanical Ventilation Pressure HighNCT06393179
Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients
A study testing pressure-volume curve with a low-flow insufflation of 5 L/min in people with Mechanical Ventilation Pressure High and Critical Illness, run by Southeast University, China at 1 site in China.
Trial summary
Monitoring airway pressure is essential for patients with mechanical ventilation. However, static airway pressure does not reflect alveolar pressure at all. Airway pressure is supposed to completely interrupt the communication between proximal airway opening and the distal alveolar and/or small airway structures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Pressure High, Critical Illness
- What is being tested?
- pressure-volume curve with a low-flow insufflation of 5 L/min
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing controlled mechanical ventilation
- The duration of endotracheal intubation < 48 hrs
Who cannot join
- Severe hemodynamic instability
- Severe chronic lung disease requiring long-term home oxygen therapy
- Patients without analgesic sedation
- Decline to participate in the study
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
xueyan yuan, phD contact
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210000
ling liu, phD, 86-25-83272201, liulingdoctor@126.com
About this study
Monitoring airway pressure is essential for patients with mechanical ventilation. However, static airway pressure does not reflect alveolar pressure at all. Airway pressure is supposed to completely interrupt the communication between proximal airway opening and the distal alveolar and/or small airway structures. In this condition, some alveoli may still be inflated but do not communicate with proximal airways and auto-PEEP will give a biased estimated of mean alveolar pressure. To be note, distinguishing the airway closure and alveolar collapse can be challenging at times. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, which may help us to identify the airway closure and alveolar collapse. Meanwhile, the quasi-static PV curve can only reflects a global behaviour of the lung, while EIT may be a useful tool to assess the regional information on airway closure and alveolar collapse.
- Being tested
- pressure-volume curve with a low-flow insufflation of 5 L/min
- Keywords
- mechanical ventilation, airway closure, alveolar collapse
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure-volume curve with a low-flow insufflation of 5 L/minOther
The patient undergoes a pressure-volume curve with a low-flow insufflation of 5 L/min while in a state of analgesia, sedation, and absence of spontaneous breathing.
| Study group | Role | What they receive |
|---|---|---|
| P-V curve group | Experimental | Enrolled patients will receive a PV curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O to a maximal airway pressure corresponding to the plateau pressure. Receives: Other: pressure-volume curve with a low-flow insufflation of 5 L/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of airway closure and alveolar collapse
airway closure and alveolar collapse are monitored by PV curve with a low-flow insufflation of 5 L/min
Measured: up to 24 hours
Phenotype of respiratory open pressure
According to the characteristics of the low inflation point of PV curve, the respiratory open pressure phenotype was constructed
Measured: up to 24 hours
Secondary outcomes (1)
respiratory system compliance
Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start30 May 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- ling liu, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393179
- Sponsor's protocol ID
- OPEN-RESPIRATORY
- Status last verified
- Aug 2024
- First submitted
- 27 Apr 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06393179
- Acronym / sponsor ID
- OPEN-RESPIRATORY
- Keywords
- mechanical ventilation, airway closure, alveolar collapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 1 May 2024 (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.
Monitoring airway pressure is essential for patients with mechanical ventilation. However, static airway pressure does not reflect alveolar pressure at all. Airway pressure is supposed to completely interrupt the communication between proximal airway opening and the distal alveolar and/or small airway structures. In this condition, some alveoli may still be inflated but do not communicate with proximal airways and auto-PEEP will give a biased estimated of mean alveolar pressure. To be note, distinguishing the airway closure and alveolar collapse can be challenging at times. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, which may help us to identify the airway closure and alveolar collapse. Meanwhile, the quasi-static PV curve can only reflects a global behaviour of the lung, while EIT may be a useful tool to assess the regional information on airway closure and alveolar collapse.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P-V curve group | Experimental | Other: pressure-volume curve with a low-flow insufflation of 5 L/minEnrolled patients will receive a PV curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O to a maximal airway pressure corresponding to the plateau pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing controlled mechanical ventilation
- The duration of endotracheal intubation < 48 hrs
Key exclusion criteria (5 listed)
- Severe hemodynamic instability
- Severe chronic lung disease requiring long-term home oxygen therapy
- Patients without analgesic sedation
- Decline to participate in the study
- Refusal to sign informed consent
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 |
|---|---|---|
| pressure-volume curve with a low-flow insufflation of 5 L/minThe patient undergoes a pressure-volume curve with a low-flow insufflation of 5 L/min while in a state of analgesia, sedation, and absence of spontaneous breathing. | Other | P-V curve group |
Primary outcome
the rate of airway closure and alveolar collapse
Time frame: up to 24 hours
airway closure and alveolar collapse are monitored by PV curve with a low-flow insufflation of 5 L/min
Phenotype of respiratory open pressure
Time frame: up to 24 hours
According to the characteristics of the low inflation point of PV curve, the respiratory open pressure phenotype was constructed
1 secondary outcome
respiratory system compliance
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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. This study is not recruiting at the moment.
xueyan yuan, phD contact
ling liu principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pressure-volume curve with a low-flow insufflation of 5 L/min in people with Mechanical Ventilation Pressure High and Critical Illness, run by Southeast University, China at 1 site 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ling liu, phD (15901599659, liulingdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of airway closure and alveolar collapse (time frame: up to 24 hours). The study lists 2 primary outcomes in all. 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 16 Aug 2024.