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NCT Number: NCT06783777

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

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.

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Key information

Conditions

Respiratory Distress Syndrome (RDS) Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Ilness Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esophageal pressure monitoring

Device

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

Tracheotomy tip pressure

Device

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

Primary outcomes

  1. Correlation between esophageal pressure and tracheotomy tip pressure

    Time frame: 2 hour

Study contacts

Contact information is provided by the study sponsor or research team.

Minjie Ju

CONTACT

[email protected]

086-13817014079

Yaxiaerjiang Muhetaer

CONTACT

[email protected]

086-15021891200

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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