NCT03880864

Brief Summary

Lung aeration loss can be measured via lung ultrasound, it is a non-invasive, bed side procedure, which can be performed rapidly and facilitates a dynamic assessment of lung aeration. Aim of the work: is to determine the role of lung ultrasound score as one of the predictors of successful weaning from mechanical ventilation in ICU 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
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

2 active sites

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

March 7, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

March 17, 2019

Last Update Submit

December 2, 2019

Conditions

Weaning Failure

Keywords

Lung ultrasound scoreWeaningMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Number of patients with lung ultrasound score of less than 13

    Successful weaning: patients who will not need re-intubation within 48 hours after extubation.

    48 hours

Interventions

UltrasoundRADIATION

Lung ultrasound

Eligibility Criteria

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

You may qualify if:

  • adult patients over 18 years.
  • Mechanically ventilated via an endotracheal tube for more than 24 hours.
  • Patients that have an improvement in the underlying cause of respiratory failure.

You may not qualify if:

  • Patients with tracheostomy
  • Spinal cord injury above than T8
  • Arrhythmias and or haemodynamic instability
  • Patients having pneumothorax, or pneumomediastinum, chest tube or chest injuries.
  • After thoracostomy, and pleural lesions or pleurodesis.
  • Patients having severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume less than 50% of predictive value.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Randa Ali Shoukry

Cairo, Al-Nozha, 11843, Egypt

RECRUITING

Randa Ali Shoukry

Cairo, Al-Nozha, 11843, Egypt

RECRUITING

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Randa A Shoukry

CONTACT

002-01001404426randa_shoukry@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 19, 2019

Study Start

March 7, 2019

Primary Completion

December 2, 2019

Study Completion

January 2, 2020

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)