NCT05289960

Brief Summary

Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU. Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

March 2, 2022

Last Update Submit

March 21, 2022

Conditions

Lung Ultrasound ScoreAcute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Extubation success

    number of participants that do not need for respiratory support neither NIV nor intubation for one week during ICU stay

    48 hours

Study Arms (2)

patients eligible for weaning by spontaneous breathing trial

OTHER
Other: lung ultrasound

non invasive ventilation after weaning

OTHER
Other: lung ultrasound

Interventions

lung ultrasoundOTHER

Lung ultrasound score was done at the end of SBT using curved array ultrasound probe 2-5 MHz, Siemens X300, Korea

non invasive ventilation after weaningpatients eligible for weaning by spontaneous breathing trial

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 1. Patients age \> 18 years
  • \. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.

You may not qualify if:

  • \. Patients \< or =18 years 2. Patients with left ventricular failure
  • \. Right ventricular failure
  • \. Pulmonary hypertension
  • \. Aortic valve disease
  • \. Hyperthyroidism
  • \. Tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, 11345, Egypt

Location

Study Officials

  • farouk faris, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 22, 2022

Study Start

December 1, 2020

Primary Completion

February 28, 2022

Study Completion

March 1, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations

EG(1)