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Not yet recruiting NCT06783777

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

No phase Interventional Respiratory Distress Syndrome (RDS) Respiratory Ilness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esophageal pressure monitoring, Tracheotomy tip pressure.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome (RDS), Respiratory Ilness. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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

Primary outcome measures

  • Correlation between esophageal pressure and tracheotomy tip pressure [Time frame: 2 hour]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • Zhongshan hospital afraid of Fudan university — Shanghai

Identifiers

NCT: NCT06783777 · B2024-526R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗