Lung UltrasoundCBPNCT03619525
Ultrasonographic Assessment of the Effect of CPB Acute Lung Injury
A study testing lung recruitment in people with Lung Ultrasound, run by Cairo University at 1 site in Egypt.
Trial summary
The study is designed to use the lung ultrasound to assess the effect of intermittent lung recruitment during cardiopulmonary bypass in cardiac surgeries on extra vascular lung water. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Ultrasound
- What is being tested?
- lung recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2018to 5 Dec 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aged (18-60 years),
- elective valvular cardiac surgery with cardiopulmonary bypass (CPB).
Who cannot join
- • Emergency surgeries.
- coronary artery bypass graft surgery
- patients requiring re-exploration in the immediate postoperative period (within 2hours)
- left Ventricular ejection fraction less than 40%
- patients with preoperative congestive heart failure, cardiogenic shock , preoperative pulmonary edema
- pre-existing severe chronic pulmonary dysfunction (defined as pulmonary disease requiring home oxygen therapy or causing shortness of breath after 1 to 2 flights of stairs)
- Morbid obesity
- Renally impaired patients with creatinine more than 2 mg/dl
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Manil, 15699
maged gendy, 01003620361, magedabdelwahab@yahoo.com
About this study
Official title: Bedside Lung Ultrasound to Assess Lung Recruiting Maneuver With Cardiopulmonary Bypass in Valvular Cardiac Surgery.
The study is designed to use the lung ultrasound to assess the effect of intermittent lung recruitment during cardiopulmonary bypass in cardiac surgeries on extra vascular lung water.
Read the detailed description
Significant respiratory dysfunction is a common problem after cardiac surgery, with an incidence of about 25%. the formation of atelectasis appears to be the primary factor responsible for increased intrapulmonary shunt after cardiac surgery with CPB. The investigators will use the lung ultrasound to evaluate the effects of intermittent recruitment of the lungs during CPB on extra vascular lung water (EVLW).
Objectives :
To evaluate the effect of intermittent lung recruitment during CPB in cardiac surgery on:
Lung ultrasound score (LUS),Oxygenation at different times postoperatively,Time for extubation and length of ICU stay
sixty patients aged from 18-60 years old, scheduled for elective cardiac surgery with CPB will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=30): will receive intermittent lung recruitment during CPB.Group B (n=30): control group.
- Conditions
- Lung Ultrasound
- Being tested
- lung recruitment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitmentProcedure or surgery
During bypass, patients in this group will receive a lung protective design in the form of continuous positive airway pressure (CPAP) by closing APL valve at pressure of 5 Cm H2o combined with intermittent recruitment by sustained manual lung inflation at a pressure of 35 cmH2O for 30 seconds every (30-40) minute
| Study group | Role | What they receive |
|---|---|---|
| recruitment group | Active comparator | will receive intermittent lung recruitment during CPB Receives: Procedure: lung recruitment |
| control group | No intervention | will recieve no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound score
- The change of lung ultrasound score (a score ranging fom 0/36 to 36/36 where 0/36 is best while 36/36 is worst) from the baseline values for assessment of extra vascular lung water after CBP
Measured: Baseline,immediately at the end of operation. 2 hours after ICU admission
Secondary outcomes (4)
• The value of Doppler derived E/E' ratio.
Measured: Baseline,immediately at the end of operation. 2 hours after ICU admission
• Oxygenation (po2),& (po2/fio2)
po2 is measured by mmhg units while PO2/fio2 is ratio
Measured: Baseline,immediately at the end of operation. 2 hours after ICU admission
• Time for extubation
Measured: before extubation
Length of ICU stay
Measured: before discharge to ward up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start20 Oct 2018
- Primary completion20 Nov 2018 (estimated)
- Study completion5 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung UltrasoundStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- sixty patients aged from 18-60 years old, scheduled for elective cardiac surgery with CPB will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=30): will receive intermittent lung recruitment during CPB.Group B (n=30): control group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Abdel-Wahab Abdel-Aziz, Cairo University
- Investigators
- ahmed agaty, professor, Principal investigator, cairro university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619525
- Sponsor's protocol ID
- lung ultrasound after CPB
- Acronym
- CBP
- Status last verified
- Oct 2018
- First submitted
- 25 Jul 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
PubMed 16984837
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Lung Ultrasound to Assess Lung Recruiting Maneuver With Cardiopulmonary Bypass in Valvular Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT03619525
- Acronym / sponsor ID
- CBP / lung ultrasound after CPB
- Conditions
- Lung Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 20 Nov 2018 (estimated)
- Study completion
- 5 Dec 2018 (estimated)
- First posted
- 8 Aug 2018 (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 study is designed to use the lung ultrasound to assess the effect of intermittent lung recruitment during cardiopulmonary bypass in cardiac surgeries on extra vascular lung water.
Detailed description
Significant respiratory dysfunction is a common problem after cardiac surgery, with an incidence of about 25%. the formation of atelectasis appears to be the primary factor responsible for increased intrapulmonary shunt after cardiac surgery with CPB. The investigators will use the lung ultrasound to evaluate the effects of intermittent recruitment of the lungs during CPB on extra vascular lung water (EVLW).
Objectives :
To evaluate the effect of intermittent lung recruitment during CPB in cardiac surgery on:
Lung ultrasound score (LUS),Oxygenation at different times postoperatively,Time for extubation and length of ICU stay
sixty patients aged from 18-60 years old, scheduled for elective cardiac surgery with CPB will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=30): will receive intermittent lung recruitment during CPB.Group B (n=30): control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- sixty patients aged from 18-60 years old, scheduled for elective cardiac surgery with CPB will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=30): will receive intermittent lung recruitment during CPB.Group B (n=30): control group.
| Arm | Type | Receives |
|---|---|---|
| recruitment group | Active comparator | Procedure: lung recruitmentwill receive intermittent lung recruitment during CPB |
| control group | No intervention | –will recieve no intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients aged (18-60 years),
- elective valvular cardiac surgery with cardiopulmonary bypass (CPB).
Key exclusion criteria (8 listed)
- • Emergency surgeries.
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 recruitmentDuring bypass, patients in this group will receive a lung protective design in the form of continuous positive airway pressure (CPAP) by closing APL valve at pressure of 5 Cm H2o combined with intermittent recruitment by sustained manual lung inflation at a pressure of 35 cmH2O for 30 seconds every (30-40) minute | Procedure or surgery | recruitment group |
Primary outcome
lung ultrasound score
Time frame: Baseline,immediately at the end of operation. 2 hours after ICU admission
• The change of lung ultrasound score (a score ranging fom 0/36 to 36/36 where 0/36 is best while 36/36 is worst) from the baseline values for assessment of extra vascular lung water after CBP
4 secondary outcomes
• The value of Doppler derived E/E' ratio.
Time frame: Baseline,immediately at the end of operation. 2 hours after ICU admission
• Oxygenation (po2),& (po2/fio2)
Time frame: Baseline,immediately at the end of operation. 2 hours after ICU admission
• Time for extubation
Time frame: before extubation
Length of ICU stay
Time frame: before discharge to ward up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Background: PubMed 16984837Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Ultrasound
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Active, not recruiting
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules
Lung Cancer, Lung; Node
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
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.
ahmed agaty, professor principal investigator
cairro 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 recruitment in people with Lung Ultrasound, run by Cairo 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 8 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 23 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maged el gendy, assiststant lecturer (2001003620361, magedabdelwahab@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung ultrasound score (time frame: Baseline,immediately at the end of operation. 2 hours after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619525, which also lists 1 linked publication.
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 23 Oct 2018.