NCT07235956

Brief Summary

This study will provide individualized objective indicators for patients undergoing invasive mechanical ventilation. It will set specific assessment parameters for weaning and extubation for different patients, increase the success rate of weaning, avoid the damage and medical risks of re-intubation, and shorten the hospital stay. The main observation targets of this study are: whether weaning is successful; the secondary targets are: specific numerical values of diaphragmatic mobility along the midclavicular line and midaxillary line, oxygenation index, and whether re-intubation occurs within 48 hours. This study is an observational study. The expected study duration is 18 months, and there is no risk of study interruption.

Trial Health

65
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2025

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 Progress44%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

September 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

September 23, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Diaphragmatic mobilityInvasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • The success rate of weaning from invasive mechanical ventilation

    From enrollment to the outcome of extubation with invasive mechanical ventilation

Study Arms (1)

Group with successful extubation of invasive mechanical ventilation

Diagnostic Test: Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning.

Interventions

Observe the ratio of diaphragmatic excursion between the midaxillary line and the midclavicular line in the successful group of invasive mechanical ventilation weaning.

Group with successful extubation of invasive mechanical ventilation

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is an observational cohort study. Patients who received invasive mechanical ventilation in the intensive care unit of our hospital from October 1, 2025 to December 31, 2026 were collected. The diaphragmatic excursion at the midclavicular line and the midaxillary line of each patient was measured using ultrasound, and the ratio of the diaphragmatic excursion at the two lines was calculated. The main content was to monitor the diaphragmatic excursion at the midclavicular line and the midaxillary line, and calculate the ratio; the monitoring time points were the first day, the third day, the seventh day (if applicable), the 14th day (if applicable), and before weaning and extubation, and at the same time, the patients' serum albumin, serum prealbumin, hemoglobin, oxygenation index, etc. were observed for treatment.

You may qualify if:

  • Patients who were admitted to the ICU and had invasive mechanical ventilation for more than 72 hours.

You may not qualify if:

  • Patients with irreversible multi-organ failure; Patients with advanced tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Qingjiang Zheng, Master of Clinical Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

September 23, 2025

First Posted

November 19, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

We have signed a personal informed consent form with the patient, and the patient's private information is protected from disclosure.