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

Fudan University

Status: Not yet enrolling

Conditions: Respiratory Distress Syndrome (RDS); Respiratory Ilness

Treatments: Device: Tracheotomy tip pressure; Device: Esophageal pressure monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06783777

B2024-526R

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)