A SBT-based Protocol-directed Program in Difficult-to-Wean Patients

NCT ID: NCT05035355

Last Updated: 2021-09-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. The investigators aimed to determine whether spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula (HFNC) could be superior to routine SBT-based weaning in reducing the duration of mechanical ventilation (MV) in difficult-to-wean patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiration, Artificial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

weaning protocol group

spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula group

Group Type EXPERIMENTAL

a weaning protocol

Intervention Type PROCEDURE

a weaning protocol that is combined spontaneous breathing trial (SBT) with the high-flow nasal cannula (HFNC)

routine SBT weaning group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

a weaning protocol

a weaning protocol that is combined spontaneous breathing trial (SBT) with the high-flow nasal cannula (HFNC)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age ≥ 16 years old
* MV for more than 48 hours
* intubated or tracheostomized

Exclusion Criteria

* pregnancy
* irreversible respiratory failure caused by neurodegenerative disorders, such as Alzheimer disease, motor neuron disease, or multiple system atrophy
* pre-existing decision to limit life support
* waiving of MV during treatment
* terminal stage of severe illness
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

JinyanXing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

JinyanXing

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jinyan Xing, Doctor

Role: CONTACT

86-0532-82919386 ext. 82919386

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jinyan Xing, Dr.

Role: primary

86-0532-82919386 ext. 82919386

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QYFYWZLL26347

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.