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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05794867
Other study ID # icu- 4-23
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date March 19, 2023

Study information

Verified date March 2023
Source King Abdul Aziz Specialist Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

compare and evaluate the effect of use of ultrasonic criteria of weaning versus the conventional ways of weaning in post-traumatic acute respiratory distress syndrome (ARDS) patients who were ventilated for a long time. And compare their effect on the duration of ICU stay.


Description:

It is a prospective double blind study done on total 200 patients. Who were weaned from ventilator after being ventilated for > one week due to respiratory failure. This respiratory failure was selected in our study to be from severe lung contusion and post-traumatic acute respiratory distress syndrome. Patients were randomly allocated in one of two groups each group contain 100 patients. Group A considered control group. Those patients weaned from the ventilator by the conventional criteria of weaning. While group B weaned from the ventilator by the ultrasound criteria of weaning. All patients weaned from both groups followed for six days for signs of failure of weaning ,signs of post-extubation respiratory failure. And number of patients who were re-ventilated and who discharged from ICU in both groups recorded and compared.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date March 19, 2023
Est. primary completion date March 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - adult patients between 18-65 years old, - with Acute respiratory distress syndrome, - any ventilated patients for more than one week Exclusion Criteria: - young or pediatric patients below 18 years. - patients older than 65 years - patients had Chronic Respiratory Disease

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
clinical weaning criteria
Xray chest and calculation of thr rapid shallow breathing rate

Locations

Country Name City State
Saudi Arabia King abd el Aziz specialist hospital Ta'if

Sponsors (1)

Lead Sponsor Collaborator
King Abdul Aziz Specialist Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of patients who had no failure of weaning patients followed by ultrasounds criteria 6 days
Secondary The number of patients who discharged early from ICU 6 days
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