Ultrasonic Weaning Criteria in Prolonged Ventilation

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Saudi Arabia
  • Ta'if, Saudi Arabia, 21944
    • King abd el Aziz specialist hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients who had no failure of weaning	patients followed by ultrasounds criteria	6 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of patients who discharged early from ICU	6 days

Collaborators and Investigators

• Sponsor: King Abdul Aziz Specialist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 19, 2023
• Study Completion (Actual): March 19, 2023

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: icu- 4-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the data is only laboratory data and figures read from the ventilator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No