NCT05035355

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

August 30, 2021

Last Update Submit

September 3, 2021

Conditions

Respiration, Artificial

Keywords

Protocol-directed weaningMechanical ventilationHigh-flow nasal cannulaSpontaneous breathing trial

Outcome Measures

Primary Outcomes (1)

  • mechanical ventilation days

    the duration of mechanical ventilation

    60 days

Secondary Outcomes (1)

  • re-intubated within 24 hours

    24 hours

Study Arms (2)

weaning protocol group

EXPERIMENTAL

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

Procedure: a weaning protocol

routine SBT weaning group

NO INTERVENTION

Interventions

a weaning protocolPROCEDURE

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

weaning protocol group

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266555, China

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jinyan Xing, Doctor

CONTACT

86-0532-82919386xingjy@qdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 5, 2021

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

CN(1)