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

NCT ID: NCT06783777

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-05

Study Completion Date

2026-12-26

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress Syndrome (RDS) Respiratory Ilness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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Esophageal pressure monitoring

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

Intervention Type DEVICE

Tracheotomy tip pressure

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan hospital afraid of Fudan university

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Minjie Ju

Role: CONTACT

086-13817014079

Yaxiaerjiang Muhetaer

Role: CONTACT

086-15021891200

Facility Contacts

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Minjie Ju

Role: primary

086-13817014079

Yaxiaerjiang Muhetaer

Role: backup

086-15021891200

Other Identifiers

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B2024-526R

Identifier Type: -

Identifier Source: org_study_id

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