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Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03921112
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intensive Care (ICU) Device: lung ultrasound Other: routine tools Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients :Prospective , Randomized Double-blinded Study
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: lung ultrasound Device: lung ultrasound
bedside lung ultrasound will be done for patients

Other: routine tools
chest X-ray , ABG, RSBI, Ventilator parameters will be done for all patients
Active Comparator: x-ray, ABG, RSBI, Vetilator parameters Other: routine tools
chest X-ray , ABG, RSBI, Ventilator parameters will be done for all patients


Outcome Measures
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Primary Outcome Measures :
  1. success of weaning [ Time Frame: success of weaning for 48 hours ]
    trans-thoracic lung ultrasound will be done to patients to start weaning


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mechanically ventilated patients
  • ASAI ,ASAII, ASAIII

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921112


Locations
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Egypt
Ain Shams University hospitals
Cairo, Egypt, 11591
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Amin m Alansary Ain Shams University
More Information
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Responsible Party: Amin Mohammed Alansary Amin Ahmed Helwa, Assistant professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03921112    
Other Study ID Numbers: FMASU R26/2019
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No