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NCT Number: NCT06424314

Exploration of Mechanisms for Weaning Failure

This study is a prospective physiologic study. The primary study population will be adult invasive tracheal intubated patients with COPD, and investigators will collect relevant demographic data, vital signs, and baseline physiologic parameters of the patients prior to the spontaneous breathing test（SBT).

The participants will be divided into a successful withdrawal group and a failed withdrawal group according to the SBT outcome, and the changes in the above parameters during SBT will be compared between the two groups .

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Key information

Conditions

Weaning Failure Central Respiratory Depression Diaphragm Injury Phrenic Nerve Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This observational study mainly include participants who had invasive mechanical ventilation for ≥48 h and are assessed to be ready for the SBT trial.The SBT approach is based on the low-level pressure support mode.

Prior to the SBT trial, baseline demographic and physiologic data of the participants will be collected, and the participants will be divided into two groups based on the results of the SBT trial: successful and unsuccessful, and the physiologic changes during the SBT trial will be compared between the two groups, respectively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Invasive mechanical ventilation for at least 48 hours

Exclusion criteria

  • neuromuscular disease；Postoperative patients or patients with traumatic brain injury

Treatment and study plan

Monitoring of respiratory mechanics parameters

Diagnostic Test

Physiologic recording instrumentation measure maximal transdiaphragmatic pressure，twitch diaphragmatic pressure and maximal diaphragmatic electromyography

Primary outcomes

  1. weaning success

    Time frame: Day 2

    passed SBT trial and weaning from mechanical ventilation success with no need of reintubation

Study contacts

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

Lili Guan, MD & PhD

CONTACT

[email protected]

020-81566675

Qiaoyun Huang

CONTACT

[email protected]

020-81566675

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

Changes in Respiratory Mechanics in Patients With Failed Ventilator Withdrawal

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2024
Registry last updated
Jul 9, 2024

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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