Weaning FailurePhase 1NCT03880864
Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation
A Phase 1 study testing Ultrasound in people with Weaning Failure, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Lung aeration loss can be measured via lung ultrasound, it is a non-invasive, bed side procedure, which can be performed rapidly and facilitates a dynamic assessment of lung aeration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 7 Mar 2019to 2 Jan 2020
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 adult patients over 18 years.
- Mechanically ventilated via an endotracheal tube for more than 24 hours.
- Patients that have an improvement in the underlying cause of respiratory failure.
Who cannot join
- Patients with tracheostomy
- Spinal cord injury above than T8
- Arrhythmias and or haemodynamic instability
- Patients having pneumothorax, or pneumomediastinum, chest tube or chest injuries.
- After thoracostomy, and pleural lesions or pleurodesis.
- Patients having severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume less than 50% of predictive value.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Randa Ali Shoukry
Cairo, Al-Nozha, 11843
Randa A Shoukry, 1001404426, randa_shoukry@hotmail.com
- Recruiting
Randa Ali Shoukry
Cairo, Al-Nozha, 11843
Randa A Shoukry, 01001404426, randa_shoukry@hotmail.com
About this study
Official title: Application of Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation
Lung aeration loss can be measured via lung ultrasound, it is a non-invasive, bed side procedure, which can be performed rapidly and facilitates a dynamic assessment of lung aeration. Aim of the work: is to determine the role of lung ultrasound score as one of the predictors of successful weaning from mechanical ventilation in ICU patients.
Read the detailed description
Patients should be assessed daily for their readiness to be weaned from mechanical ventilation, sedation must be withdrawn and all patients will be put on a spontaneous breathing trial (SBT), via T-piece, for 60 -120 minutes period, when they fulfil the weaning criteria. Patients who succeed to tolerate SBT will be extubated and monitored for signs of respiratory distress.
Clinical assessment during and after SBT:
- The ability of maintaining a respiration rate of less than 35/min, and keeping oxygen saturation more than 90%.
- Arterial blood gases (ABGs) will be done 30-60 minutes after SBT and after extubation.
- To detect signs of respiratory distress: diaphoresis, tachypnea (RR> 35/min), increase activity of accessory muscles of respiration, tachycardia (heart rate > 140 beats per minute), systolic blood pressure > 180 mmHg or <90 mmHg, appearance of new arrhythmia, or alteration in mental status (drowsiness or anxiety). ABGs: PaO2 ≤ 60 mmHg or oxygen saturation < 90% on FiO2 ≥ 0.4, PaCO2 > 50 mmHg, or an increase in by ≥ 8 mmHg, pH < 7.32 or a decrease in pH by ≥ 0.07 pH units.
Clinical assessment will be done by an intensivist who will be blinded to the LUS score results.
Lung ultrasound (LUS): will be performed while patients in supine position, with a curved probe on B- mode, using longitudinal view, to assess the amount of lung aeration. Each lung will be divided into anterior, lateral and posterior regions, each part will be divided to upper and lower zone, with total of 12 zones to undergo examination. Examination will be done by an expert physician in US.
Lung US score [9]: The 12 scanned regions will be summed to calculate the LUS score, which ranged from 0 and 36. In each zone, the worst ultrasound form will considered to be descriptive of the entire region.
- Score of 0: Normal aeration is signified by the presence of horizontal A lines, lung sliding, or less than 3 vertical B lines.
- Score of 1: moderate loss of aeration is characterized by multiple regularly or irregularly spaced B lines that originated from the pleural line.
- Score of 2: Severe loss of aeration is manifested by multiple coalescent B lines in several intercostal spaces of the specific zone. Detected in alveolar-interstitial syndrome.[
- Score of 3: Complete loss of aeration, as detected in lung consolidation or atelectasis, is characterized by tissue echogenicity, which is similar to liver or splenic tissues.
The score will be performed before starting and at the end of SBT (before extubation), or on developing respiratory distress during SBT.
Patients will be classified according to the possible outcome:
Successful weaning: patients who will not need re-intubation within 48 hours after extubation.
SBT failure: which will be diagnosed by the appearance of signs of respiratory distress during SBT and patients will be connected again to the ventilator. Extubation failure: will be defined as patients who developed signs of respiratory distress after extubation within 48hs and need reintubation or non-invasive ventilatory support.
- Conditions
- Weaning Failure
- Being tested
- Ultrasound
- Keywords
- Lung ultrasound score, Weaning, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
Lung ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with lung ultrasound score of less than 13
Successful weaning: patients who will not need re-intubation within 48 hours after extubation.
Measured: 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 Mar 2019
- Study start7 Mar 2019
- Primary completion2 Dec 2019 (estimated)
- Study completion2 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Ali Shoukry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880864
- Sponsor's protocol ID
- FMASU R 12/2019
- Status last verified
- Dec 2019
- First submitted
- 17 Mar 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03880864
- Acronym / sponsor ID
- FMASU R 12/2019
- Conditions
- Weaning Failure
- Keywords
- Lung ultrasound score, Weaning, Mechanical ventilation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 2 Dec 2019 (estimated)
- Study completion
- 2 Jan 2020 (estimated)
- First posted
- 19 Mar 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.
Lung aeration loss can be measured via lung ultrasound, it is a non-invasive, bed side procedure, which can be performed rapidly and facilitates a dynamic assessment of lung aeration. Aim of the work: is to determine the role of lung ultrasound score as one of the predictors of successful weaning from mechanical ventilation in ICU patients.
Detailed description
Patients should be assessed daily for their readiness to be weaned from mechanical ventilation, sedation must be withdrawn and all patients will be put on a spontaneous breathing trial (SBT), via T-piece, for 60 -120 minutes period, when they fulfil the weaning criteria. Patients who succeed to tolerate SBT will be extubated and monitored for signs of respiratory distress.
Clinical assessment during and after SBT:
- The ability of maintaining a respiration rate of less than 35/min, and keeping oxygen saturation more than 90%.
- Arterial blood gases (ABGs) will be done 30-60 minutes after SBT and after extubation.
- To detect signs of respiratory distress: diaphoresis, tachypnea (RR> 35/min), increase activity of accessory muscles of respiration, tachycardia (heart rate > 140 beats per minute), systolic blood pressure > 180 mmHg or <90 mmHg, appearance of new arrhythmia, or alteration in mental status (drowsiness or anxiety). ABGs: PaO2 ≤ 60 mmHg or oxygen saturation < 90% on FiO2 ≥ 0.4, PaCO2 > 50 mmHg, or an increase in by ≥ 8 mmHg, pH < 7.32 or a decrease in pH by ≥ 0.07 pH units.
Clinical assessment will be done by an intensivist who will be blinded to the LUS score results.
Lung ultrasound (LUS): will be performed while patients in supine position, with a curved probe on B- mode, using longitudinal view, to assess the amount of lung aeration. Each lung will be divided into anterior, lateral and posterior regions, each part will be divided to upper and lower zone, with total of 12 zones to undergo examination. Examination will be done by an expert physician in US.
Lung US score [9]: The 12 scanned regions will be summed to calculate the LUS score, which ranged from 0 and 36. In each zone, the worst ultrasound form will considered to be descriptive of the entire region.
- Score of 0: Normal aeration is signified by the presence of horizontal A lines, lung sliding, or less than 3 vertical B lines.
- Score of 1: moderate loss of aeration is characterized by multiple regularly or irregularly spaced B lines that originated from the pleural line.
- Score of 2: Severe loss of aeration is manifested by multiple coalescent B lines in several intercostal spaces of the specific zone. Detected in alveolar-interstitial syndrome.[
- Score of 3: Complete loss of aeration, as detected in lung consolidation or atelectasis, is characterized by tissue echogenicity, which is similar to liver or splenic tissues.
The score will be performed before starting and at the end of SBT (before extubation), or on developing respiratory distress during SBT.
Patients will be classified according to the possible outcome:
Successful weaning: patients who will not need re-intubation within 48 hours after extubation.
SBT failure: which will be diagnosed by the appearance of signs of respiratory distress during SBT and patients will be connected again to the ventilator. Extubation failure: will be defined as patients who developed signs of respiratory distress after extubation within 48hs and need reintubation or non-invasive ventilatory support.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 adult patients over 18 years.
- Mechanically ventilated via an endotracheal tube for more than 24 hours.
- Patients that have an improvement in the underlying cause of respiratory failure.
Key exclusion criteria (6 listed)
- Patients with tracheostomy
- Spinal cord injury above than T8
- Arrhythmias and or haemodynamic instability
- Patients having pneumothorax, or pneumomediastinum, chest tube or chest injuries.
- After thoracostomy, and pleural lesions or pleurodesis.
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 |
|---|---|---|
| UltrasoundLung ultrasound | Radiation | – |
Primary outcome
Number of patients with lung ultrasound score of less than 13
Time frame: 48 hours
Successful weaning: patients who will not need re-intubation within 48 hours after extubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ultrasound in people with Weaning Failure, run by Ain Shams University at 2 sites 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randa A Shoukry (002-01001404426, randa_shoukry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with lung ultrasound score of less than 13 (time frame: 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 3 Dec 2019.