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Role of Point of Care Ultrasound in Endotracheal Tube Placement

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ClinicalTrials.gov Identifier: NCT04216199
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Tracking Information
First Submitted Date  ICMJE December 29, 2019
First Posted Date  ICMJE January 2, 2020
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date December 1, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2019)
Number of patients with correct placement of endotracheal tube [ Time Frame: 6 months ]
The number of patients with correct placement of endotracheal tube
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 Point of Care Ultrasound in Endotracheal Tube Placement
Official Title  ICMJE Role of Point of Care Ultrasound in Confirmation of Endotracheal Tube Placement in Children
Brief Summary Role of point of care ultrasound in endotracheal tube placement in children
Detailed Description Role of point of care ultrasound in confirmation of endotracheal tube placement in children
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Intervention  ICMJE Device: Point of care Ultrasound
Point of care Ultrasound
Other Name: POC Ultrasound
Study Arms  ICMJE
  • Experimental: Point of care Ultrasound
    Point of care Ultrasound for placement of endotracheal tube
    Intervention: Device: Point of care Ultrasound
  • No Intervention: Traditional
    Traditional method of insertion of endotracheal tube
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 29, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2030
Estimated Primary Completion Date December 1, 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children below 18 years needing endotracheal intubation.

Exclusion Criteria:

  • Age more than 18 years.
  • Patients with significant neck or lung pathology.
  • Patients with elective intubation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04216199
Other Study ID Numbers  ICMJE elbahnasawy
Has Data Monitoring Committee Yes
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
Plan to Share IPD: No
Responsible Party Sherief Abd-Elsalam, Tanta University
Study Sponsor  ICMJE Sherief Abd-Elsalam
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fekry khater, Msc Emergency medicine department - Alazhar University
Principal Investigator: Mohamed S Sharaf, Prof. Anasthesia and Pain department - Alazhar University
Study Director: Mohamed H Elshafey, Prof Radiodiagnosis Department - Tanta University
Study Director: Mohamed G Elbahnasawy, Lecturer Emergency medicine department - Tanta University
PRS Account Tanta University
Verification Date December 2019

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