NCT06783777

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2026

Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

January 15, 2025

Last Update Submit

January 15, 2025

Conditions

Respiratory Distress Syndrome (RDS)Respiratory Ilness

Keywords

esophageal-pressuretracheotomy tip pressure

Outcome Measures

Primary Outcomes (1)

  • Correlation between esophageal pressure and tracheotomy tip pressure

    2 hour

Interventions

Esophageal pressure monitoringDEVICE

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

Tracheotomy tip pressureDEVICE

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan hospital afraid of Fudan university

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Minjie Ju

CONTACT

086-13817014079ju.minjie@zs-hospital.sh.cn

Yaxiaerjiang Muhetaer

CONTACT

086-15021891200ya.xia_erjiang@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

February 5, 2025

Primary Completion (Estimated)

June 26, 2026

Study Completion (Estimated)

December 26, 2026

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations

CN(1)