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

January 15, 2025 updated by: Shanghai Zhongshan Hospital
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between esophageal pressure and tracheotomy tip pressure
Time Frame: 2 hour
2 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 5, 2025

Primary Completion (Estimated)

June 26, 2026

Study Completion (Estimated)

December 26, 2026

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2024-526R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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