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Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy

Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06783777
Enrollment
42
Registered
2025-01-20
Start date
2025-02-05
Completion date
2026-12-26
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome (RDS), Respiratory Ilness

Keywords

esophageal-pressure, tracheotomy tip pressure

Brief 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.

Interventions

Esophageal pressure and Tracheotomy tip pressure were measured simultaneously in patients with off-line tracheotomy to verify the correlation

DEVICETracheotomy tip pressure

Esophageal pressure and tracheotomy tip pressure were measured simultaneously in patients with off-line tracheotomy to verify the correlation

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Correlation between esophageal pressure and tracheotomy tip pressure2 hour

Countries

China

Contacts

Primary ContactMinjie Ju
ju.minjie@zs-hospital.sh.cn086-13817014079
Backup ContactYaxiaerjiang Muhetaer
ya.xia_erjiang@zs-hospital.sh.cn086-15021891200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026