Back to resultsLung Ultrasound Score and Weaning Outcome
Primary Purpose
Lung Ultrasound Score, Acute Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lung ultrasound
Sponsored by
About this trial
This is an interventional health services research trial for Lung Ultrasound Score
Eligibility Criteria
Inclusion Criteria:
- 1. Patients age > 18 years
2. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.
Exclusion Criteria:
1. Patients < or =18 years 2. Patients with left ventricular failure
3. Right ventricular failure
4. Pulmonary hypertension
5. Aortic valve disease
6. Hyperthyroidism
7. Tracheostomy
Sites / Locations
- Cairo University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
patients eligible for weaning by spontaneous breathing trial
non invasive ventilation after weaning
Arm Description
Outcomes
Primary Outcome Measures
Extubation success
number of participants that do not need for respiratory support neither NIV nor intubation for one week during ICU stay
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05289960
Brief Title
Lung Ultrasound Score and Weaning Outcome
Official Title
Lung Ultrasound Score for Prediction of Weaning Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU.
Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.
Detailed Description
Methods: A prospective observational study of 50 patients planned for extubation who passed a spontaneous breathing trial, lung ultrasound score and serum level of NT-PRO BNP were done to all patients at end of spontaneous breathing trial, and all patients were followed after extubation and monitored for oxygenation, re-intubation rate, ICU stay, and ICU mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Ultrasound Score, Acute Respiratory Failure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients eligible for weaning by spontaneous breathing trial
Arm Type
Other
Arm Title
non invasive ventilation after weaning
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
lung ultrasound
Intervention Description
Lung ultrasound score was done at the end of SBT using curved array ultrasound probe 2-5 MHz, Siemens X300, Korea
Primary Outcome Measure Information:
Title
Extubation success
Description
number of participants that do not need for respiratory support neither NIV nor intubation for one week during ICU stay
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 1. Patients age > 18 years
2. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.
Exclusion Criteria:
1. Patients < or =18 years 2. Patients with left ventricular failure
3. Right ventricular failure
4. Pulmonary hypertension
5. Aortic valve disease
6. Hyperthyroidism
7. Tracheostomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
farouk faris, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
ZIP/Postal Code
11345
Country
Egypt
12. IPD Sharing Statement
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Lung Ultrasound Score and Weaning Outcome
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