NCT03921112

Brief Summary

The aim of this study is to demonstrate the role of lung ultrasound in weaning from mechanical ventilation in neurosurgical ICU patients compared to the ordinary tools as chest X-ray , ABG, rapid shallow breathing index, ventilator parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

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

April 3, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

April 17, 2019

Last Update Submit

May 18, 2020

Conditions

Intensive Care (ICU)

Outcome Measures

Primary Outcomes (1)

  • success of weaning

    trans-thoracic lung ultrasound will be done to patients to start weaning

    success of weaning for 48 hours

Study Arms (2)

lung ultrasound

ACTIVE COMPARATOR
Device: lung ultrasoundOther: routine tools

x-ray, ABG, RSBI, Vetilator parameters

ACTIVE COMPARATOR
Other: routine tools

Interventions

lung ultrasoundDEVICE

bedside lung ultrasound will be done for patients

lung ultrasound
routine toolsOTHER

chest X-ray , ABG, RSBI, Ventilator parameters will be done for all patients

lung ultrasoundx-ray, ABG, RSBI, Vetilator parameters

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanically ventilated patients
  • ASAI ,ASAII, ASAIII

You may not qualify if:

  • Patients or gurdians refuse
  • Patients with pneumthorax
  • Patients with pleural effusion
  • Patients with surgical emphysema
  • Glasco coma score more than 8
  • Patients on high inotropic support
  • patients with diaphragmatic paralysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

Study Officials

  • Amin m Alansary

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 19, 2019

Study Start

April 3, 2019

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

EG(1)