Respiratory Distress Syndrome (RDS)NCT06783777
Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy
A study testing Esophageal pressure monitoring and Tracheotomy tip pressure in people with Respiratory Distress Syndrome (RDS) and Respiratory Ilness, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Whether the correlation between gas incision tip pressure fluctuations (ΔPtt) and esophageal pressure fluctuations (ΔPes) is a potential measure of spontaneous respiratory effort in patients undergoing gas incision offline. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Respiratory Distress Syndrome (RDS), Respiratory Ilness
- What is being tested?
- Esophageal pressure monitoring and Tracheotomy tip pressure
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to 26 Dec 2026
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old), regardless of gender
- Tracheostomized patients with spontaneous breathing;
- Weaning criteria: under the condition of mask oxygen inhalation at 5L/min, SPO2 > 94%, PaO2/FiO2 > 150 - 200.
- The patient has stable hemodynamics and pH ≥ 7.32;
- Agree to participate in this trial and sign the informed consent form.
Who cannot join
- Patients with contraindications for esophageal catheter insertion and unable to monitor esophageal pressure;
- Patients with bleeding risks: severe coagulation disorders, esophageal varices；
- Local injuries: basilar skull fracture, maxillofacial fracture;
- Pregnant women;
- Patients considered not suitable by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan hospital afraid of Fudan university
Shanghai, 200032
Minjie Ju, 086-13817014079, ju.minjie@zs-hospital.sh.cn
Yaxiaerjiang Muhetaer, 086-15021891200, ya.xia_erjiang@zs-hospital.sh.cn
About this study
Whether the correlation between gas incision tip pressure fluctuations (ΔPtt) and esophageal pressure fluctuations (ΔPes) is a potential measure of spontaneous respiratory effort in patients undergoing gas incision offline.
- Being tested
- Esophageal pressure monitoring, Tracheotomy tip pressure
- Keywords
- esophageal-pressure, tracheotomy tip pressure
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal pressure monitoringDevice
Esophageal pressure and Tracheotomy tip pressure were measured simultaneously in patients with off-line tracheotomy to verify the correlation
Tracheotomy tip pressureDevice
Esophageal pressure and tracheotomy tip pressure were measured simultaneously in patients with off-line tracheotomy to verify the correlation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between esophageal pressure and tracheotomy tip pressure
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start5 Feb 2025 (estimated)
- Primary completion26 Jun 2026 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome (RDS)Studies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783777
- Sponsor's protocol ID
- B2024-526R
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy
- ClinicalTrials.gov ID
- NCT06783777
- Acronym / sponsor ID
- B2024-526R
- Keywords
- esophageal-pressure, tracheotomy tip pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 5 Feb 2025 (estimated)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 20 Jan 2025 (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.
Whether the correlation between gas incision tip pressure fluctuations (ΔPtt) and esophageal pressure fluctuations (ΔPes) is a potential measure of spontaneous respiratory effort in patients undergoing gas incision offline.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years old), regardless of gender
- Tracheostomized patients with spontaneous breathing;
- Weaning criteria: under the condition of mask oxygen inhalation at 5L/min, SPO2 > 94%, PaO2/FiO2 > 150 - 200.
- The patient has stable hemodynamics and pH ≥ 7.32;
- Agree to participate in this trial and sign the informed consent form.
Key exclusion criteria (5 listed)
- Patients with contraindications for esophageal catheter insertion and unable to monitor esophageal pressure;
- Patients with bleeding risks: severe coagulation disorders, esophageal varices；
- Local injuries: basilar skull fracture, maxillofacial fracture;
- Pregnant women;
- Patients considered not suitable by the researcher.
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 |
|---|---|---|
| Esophageal pressure monitoringEsophageal pressure and Tracheotomy tip pressure were measured simultaneously in patients with off-line tracheotomy to verify the correlation | Device | – |
| Tracheotomy tip pressureEsophageal pressure and tracheotomy tip pressure were measured simultaneously in patients with off-line tracheotomy to verify the correlation | Device | – |
Primary outcome
Correlation between esophageal pressure and tracheotomy tip pressure
Time frame: 2 hour
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 20 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal pressure monitoring and Tracheotomy tip pressure in people with Respiratory Distress Syndrome (RDS) and Respiratory Ilness, run by Shanghai Zhongshan Hospital 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 5 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: opening soon, as of the sponsor's last update on 20 Jan 2025. 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?
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 Minjie Ju (086-13817014079, ju.minjie@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between esophageal pressure and tracheotomy tip pressure (time frame: 2 hour). 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 20 Jan 2025.