Acute Respiratory Distress SyndromeNCT05794867
Ultrasonic Weaning Criteria in Prolonged Ventilation
An observational study of Acute Respiratory Distress Syndrome, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- clinical weaning criteria
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2021to 19 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- adult patients between 18-65 years old,
- with Acute respiratory distress syndrome,
- any ventilated patients for more than one week
Who cannot join
- young or pediatric patients below 18 years.
- patients older than 65 years
- patients had Chronic Respiratory Disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- clinical weaning criteria
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical weaning criteriaDiagnostic test
Also called arterial blood gases and reading on the ventilator
Xray chest and calculation of thr rapid shallow breathing rate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who had no failure of weaning
patients followed by ultrasounds criteria
Measured: 6 days
Secondary outcomes (1)
The number of patients who discharged early from ICU
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2021
- Primary completion19 Mar 2023
- Study completion19 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdul Aziz Specialist Hospital
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794867
- Sponsor's protocol ID
- icu- 4-23
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data is only laboratory data and figures read from the ventilator
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05794867
- Acronym / sponsor ID
- icu- 4-23
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- King Abdul Aziz Specialist HospitalResearch network
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 19 Mar 2023 (actual)
- Study completion
- 19 Mar 2023 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients were randomly allocated in one of two groups each group contain 100 patients. | – | Diagnostic Test: clinical weaning criteriaGroup A considered control group. Those patients weaned from the ventilator by the conventional criteria of weaning |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- adult patients between 18-65 years old,
- with Acute respiratory distress syndrome,
- any ventilated patients for more than one week
Key exclusion criteria (3 listed)
- young or pediatric patients below 18 years.
- patients older than 65 years
- patients had Chronic Respiratory Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical weaning criteriaAlso: arterial blood gases and reading on the ventilatorXray chest and calculation of thr rapid shallow breathing rate | Diagnostic test | Patients were randomly allocated in one of two groups each group contain 100 patients. |
Primary outcome
The number of patients who had no failure of weaning
Time frame: 6 days
patients followed by ultrasounds criteria
1 secondary outcome
The number of patients who discharged early from ICU
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No. the data is only laboratory data and figures read from the ventilator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who had no failure of weaning (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.