NCT04463303

Brief Summary

The aim of the work is to

  1. 1.Assess the incidence of weaning induced pulmonary adema(WIPO).
  2. 2.Assess the risk factors of WIPO.
  3. 3.Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT).
  4. 4.Detect the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy of WIPO.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 5, 2020

Last Update Submit

July 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema

    1 year

Study Arms (2)

group 1

patient who will develop weaning induced pulmonary adema

Other: lung ultrasound

group 2

patient who will nor develop weaning induced pulmonary adema

Other: lung ultrasound

Interventions

patient with or without weaning induced pulmonary adema

group 1group 2

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).

You may qualify if:

  • The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).

You may not qualify if:

  • Patients with poor lung ultrasound window, history of cardiomyopathy, significant valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic and mitral stenosis) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Internal Medicine

Study Record Dates

First Submitted

July 5, 2020

First Posted

July 9, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2020

Study Completion

July 1, 2021

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share