Intensive Care (ICU)NCT03921112
Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients
A study testing lung ultrasound and routine tools in people with Intensive Care (ICU), run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to demonstrate the role of lung ultrasound in weaning from mechanical ventilation in neurosurgical ICU patients compared to the ordinary tools as chest X-ray , ABG, rapid shallow breathing index, ventilator parameters. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intensive Care (ICU)
- What is being tested?
- lung ultrasound and routine tools
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2019to 1 Oct 2019
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanically ventilated patients
- ASAI ,ASAII, ASAIII
Who cannot join
- Patients or gurdians refuse
- Patients with pneumthorax
- Patients with pleural effusion
- Patients with surgical emphysema
- Glasco coma score more than 8
- Patients on high inotropic support
- patients with diaphragmatic paralysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients :Prospective , Randomized Double-blinded Study
The aim of this study is to demonstrate the role of lung ultrasound in weaning from mechanical ventilation in neurosurgical ICU patients compared to the ordinary tools as chest X-ray , ABG, rapid shallow breathing index, ventilator parameters.
- Conditions
- Intensive Care (ICU)
- Being tested
- lung ultrasound, routine tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundDevice
bedside lung ultrasound will be done for patients
routine toolsOther
chest X-ray , ABG, RSBI, Ventilator parameters will be done for all patients
| Study group | Role | What they receive |
|---|---|---|
| lung ultrasound | Active comparator | Not described Receives: Device: lung ultrasound; Other: routine tools |
| x-ray, ABG, RSBI, Vetilator parameters | Active comparator | Not described Receives: Other: routine tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of weaning
trans-thoracic lung ultrasound will be done to patients to start weaning
Measured: success of weaning for 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start3 Apr 2019
- Primary completion1 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care (ICU)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
- Investigators
- Amin m Alansary, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921112
- Sponsor's protocol ID
- FMASU R26/2019
- Status last verified
- May 2020
- First submitted
- 17 Apr 2019
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients :Prospective , Randomized Double-blinded Study
- ClinicalTrials.gov ID
- NCT03921112
- Acronym / sponsor ID
- FMASU R26/2019
- Conditions
- Intensive Care (ICU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 19 Apr 2019 (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.
The aim of this study is to demonstrate the role of lung ultrasound in weaning from mechanical ventilation in neurosurgical ICU patients compared to the ordinary tools as chest X-ray , ABG, rapid shallow breathing index, ventilator parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung ultrasound | Active comparator | Device: lung ultrasound, Other: routine tools |
| x-ray, ABG, RSBI, Vetilator parameters | Active comparator | Other: routine tools |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mechanically ventilated patients
- ASAI ,ASAII, ASAIII
Key exclusion criteria (7 listed)
- Patients or gurdians refuse
- Patients with pneumthorax
- Patients with pleural effusion
- Patients with surgical emphysema
- Glasco coma score more than 8
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 |
|---|---|---|
| lung ultrasoundbedside lung ultrasound will be done for patients | Device | lung ultrasound |
| routine toolschest X-ray , ABG, RSBI, Ventilator parameters will be done for all patients | Other | lung ultrasound, x-ray, ABG, RSBI, Vetilator parameters |
Primary outcome
success of weaning
Time frame: success of weaning for 48 hours
trans-thoracic lung ultrasound will be done to patients to start weaning
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 19 May 2020.
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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.
Amin m Alansary principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasound and routine tools in people with Intensive Care (ICU), run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 7 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 19 May 2020. 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 Egypt. 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?
success of weaning (time frame: success of weaning for 48 hours). 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 19 May 2020.