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出境医 / 临床实验 / Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients

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

Study Description
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
Arms and Interventions
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
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

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
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE April 3, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		success of weaning [ Time Frame: success of weaning for 48 hours ]
trans-thoracic lung ultrasound will be done to patients to start weaning
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients
Official Title  ICMJE Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients :Prospective , Randomized Double-blinded Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intensive Care (ICU)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: lung ultrasound
    Interventions:
    • Device: lung ultrasound
    • Other: routine tools
  • Active Comparator: x-ray, ABG, RSBI, Vetilator parameters
    Intervention: Other: routine tools
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2019) 		130
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921112
Other Study ID Numbers  ICMJE FMASU R26/2019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amin m Alansary Ain Shams University
PRS Account Ain Shams University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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