NCT05794867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 19, 2023

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of patients who had no failure of weaning

    patients followed by ultrasounds criteria

    6 days

Secondary Outcomes (1)

  • The number of patients who discharged early from ICU

    6 days

Study Arms (2)

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

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.

Interventions

Xray chest and calculation of thr rapid shallow breathing rate

Also known as: arterial blood gases and reading on the ventilator
Patients were randomly allocated in one of two groups each group contain 100 patients.

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsboth sex are allocated randomly in one of the two groups
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • adult patients between 18-65 years old,
  • with Acute respiratory distress syndrome,
  • any ventilated patients for more than one week

You may not qualify if:

  • young or pediatric patients below 18 years.
  • patients older than 65 years
  • patients had Chronic Respiratory Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2023

First Posted

April 3, 2023

Study Start

April 1, 2021

Primary Completion

March 19, 2023

Study Completion

March 19, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

the data is only laboratory data and figures read from the ventilator

Locations