Ultrasonic Weaning Criteria in Prolonged Ventilation

Sponsor

King Abdul Aziz Specialist Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05794867

Collaborator

(none)

200

Enrollment

Location

23.6

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Diagnostic Test: clinical weaning criteria

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Comparative Study Between Use of Ultrasonic Criteria of Weaning Versus the Conventional Criteria of Weaning in Post-traumatic Acute Respiratory Distress Syndrome Patients Who Were Ventilated for a Long Time

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Mar 19, 2023

Actual Study Completion Date :

Mar 19, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Diagnostic Test: clinical weaning criteria Xray chest and calculation of thr rapid shallow breathing rate Other Names: arterial blood gases and reading on the ventilator
100 patients 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.

Arm

Intervention/Treatment

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

Diagnostic Test: clinical weaning criteria

Xray chest and calculation of thr rapid shallow breathing rate

Other Names:

arterial blood gases and reading on the ventilator

100 patients

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.

Outcome Measures

Primary Outcome Measures

The number of patients who had no failure of weaning [6 days]
patients followed by ultrasounds criteria

Secondary Outcome Measures

The number of patients who discharged early from ICU [6 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King abd el Aziz specialist hospital	Ta'if		Saudi Arabia	21944

Sponsors and Collaborators

King Abdul Aziz Specialist Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

King Abdul Aziz Specialist Hospital

ClinicalTrials.gov Identifier:

NCT05794867

Other Study ID Numbers:

icu- 4-23

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Syndrome

Study Results

No Results Posted as of Apr 3, 2023