Coronary Artery DiseaseNCT04499027
Prognostic Value of Lung Ultrasound in Predicting Intensive Care Unit Length of Stay in Adult Cardiac Surgery
An observational study of Coronary Artery Disease and Valvular Heart Disease, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Being easy, bedside, non-expensive, noninvasive and radiation free, there has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade, cardiac surgery was not an exception in both adult and pediatric surgeries Many predictors for open heart surgery outcomes have… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- Lung ultrasound scan
- How many people
- 191 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2020to 30 Jul 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted in Fayoum uniersity hospital who are candidates for open heart surgeries
Who may be able to join
- all patients Scheduled for elective cardiac surgery for valve replacement, CABG or adult congenital (VSD or ASD) via median sternotomy
Who cannot join
- subjects with inadequate acoustic windows or incomplete examinations (as defined below),
- Patients with emergency surgeries.
- Patients with thoracic deformities or preexisting pulmonary pathology
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514
About this study
Official title: Prognostic Value of Lung Ultrasound in Predicting Intensive Care Unit Length of Stay in Adult Cardiac Surgery: A Prospective Observational Study
Being easy, bedside, non-expensive, noninvasive and radiation free, there has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade, cardiac surgery was not an exception in both adult and pediatric surgeries Many predictors for open heart surgery outcomes have been studied in past years including The Society of Thoracic Surgeons (STS) risk score and the EuroSCORE (ES), preoperative clinical condition, associated chronic diseases, type of surgery, age, duration of cardiopulmonary bypass and brain natriuretic peptide (BNP), cystatin-C A recent study described the use of a novel postoperative lung ultrasound score scanning for B lines which denote subpleural interstitial edema in various lung regions for predicting critical care length of stay in pediatric cardiac surgeries.
The objective of the current study is to evaluate the role of the new lung ultrasound score in predicting the length of postoperative intensive care stay after adult open heart surgeries.
Read the detailed description
After approval of the local institutional ethics committee and local institutional review board. All patients scheduled for open heart surgery in Fayoum university hospital starting from August 2020 will be enrolled in this prospective observational study until fulfilling sample size. A detailed informed consent will be signed by the eligible participants before recruitment ANESTHETIC TECHNIQUE All patients will be preoperatively assessed and investigated by complete blood count, coagulation profile, Liver and kidney functions and serum electrolytes. Chest X-ray, Electrocardiography (ECG) and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested if needed.
Patient will be premedicated by 10 mg morphine intramuscularly at morning of the operation. Prior to induction of anesthesia, standard monitoring will be applied including a five-lead electrocardiography system, a pulse oximeter probe. A peripheral intravenous (IV) cannula will be placed. An arterial will be inserted using a 20 G cannula either right or left radial artery under local anesthesia. After pre-oxygenation, general anesthesia will be induced using midazolam 2-5 mg, fentanyl (3-10 μg/kg), propofol (1-1.5 mg/Kg), followed by atracurium (0.5 mg/kg).
After trachea intubation, patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. A main stream capnogram, an esophageal temperature probe and a Foley catheter will also be placed. A triple-lumen central venous catheter will be placed usually through the right internal jugular vein.
Maintenance of anesthesia will be achieved by inhaled Isoflurane 0.4 to 1% and atracurium infusion at a rate of 0.5 mg/kg/h. After initiating extracorporeal circulation, Propofol infusion at a rate of 50-100 µg/kg/min will be added to replace isoflurane inhalation.
Patients will receive intravenous heparin (300-500 IU/kg body weight) before the initiation of cardiopulmonary bypass (CPB) to achieve an activated clotting time (ACT) of more than 480 seconds. Cardiopulmonary bypass was instituted with the use of a non-pulsatile blood flow at 2.4 L/min/m2, a non-heparin-coated circuit, and a membrane oxygenator. Mean arterial pressure will be adjusted to exceed 60mmHg before, during and after cardiopulmonary bypass (CBP) . Cardiac arrest will be induced using St Thomas crystalloid solution (Hamburg). Lactated Ringer's solution will be added to the CPB circuit to maintain reservoir volume if needed, and packed red blood cells will be infused when hemoglobin level drops to less than 7g/dl. After rewarming the patient to 37°C and weaning from CPB; Protamine sulfate will be used to reverse the effect of heparin.
After skin closure and wound dressing, patients will be transferred to the intensive care unit intubated with manual ventilation and full monitoring during transfer.
Intensive care Tracheal extubation will be performed when the patient meets the following criteria: awake or arousable, hemodynamically stable, no ongoing active bleeding, warm extremities, no electrolyte abnormalities, no or minimal inotropic support and a satisfactory arterial blood gas with a fraction of inspired oxygen (FiO2) < 0.5, Ventilator pressure support reduced to 10 CmH2O with Positive End Expiratory Pressure (PEEP) 5-7 CmH2O.
ICU management and decisions will be left to the intensivist who is responsible of the postoperative cardiac critical care.
Patient will be discharged from ICU when the following criteria are met: Awake patient with oxygen saturation (SpO2) < 90% at FIO2 > 0.5 by facemask, adequate cardiac stability, no intravenous inotropic or vasopressor supportive therapy, no hemodynamically significant arrhythmia, not dependent on epicardial external pacing no major bleeding i.e. chest tube drainage less than 50 ml/h, urine output of more than 0.5 ml/kg/h and no vital threats to other organ systems such as kidneys and liver.
Lung Ultrasound scan (LUS) All patients will be examined at 12 hours postoperatively as per our institution routine using a convex ultrasound probe, any other LUS will be done upon demand.
LUS will be performed by an experienced radiologist according to standardized protocols.
This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score.
Sample size was calculated using (G power). Minimal sample size of patients was 191 needed to get power level 0.80, alpha level 0.05 (two tailed) and 0.20 as expected β (slope of regression line) for predicting intensive care Length of stay .
Data management will be performed using the Statistical Package for Social Sciences (version 22.0; SPSS Inc., Chicago, IL, USA). Descriptive statistics (mean, standard deviation for quantitative data, and number and percentages for qualitative data) will be used to summarize the data. Nominal data will be analyzed using simple chi squared test, while independent sample t-test or one-way ANOVA procedure will be used to compare means for two or three groups of cases, respectively. Regression analysis will be performed to determine the predictors for LOS. A probability value (P value) ≤ 0.05 is considered significant.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Being tested
- Lung ultrasound scan
- Keywords
- Lung ultrasound, coronary artery bypass graft (CABG), open heart surgery, ICU LOS
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound scanDiagnostic test
12 hours postoperatively using a convex ultrasound probe LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior.
For each quadrant a score will be assigned based on B lines which are defined as comet like artifacts indicating subpleural interstitial edema as follows:
(0) normal aeration: A lines with lung sliding or fewer than two isolated B lines; (1) moderate loss of lung aeration: well-defined, multiple B lines ; (2) severe loss of lung aeration: multiple coalescent B lines; and (3) complete loss of lung aeration or lung consolidation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive care Length of stay
in days
Measured: from ICU admission till patient discharge to ward assessed up to 30 days
Secondary outcomes (23)
EURO Score II
calculated preoperatively using different variables which are age, gender, renal impairment, extracardiac arteriopathy, poor mobility, previous cardiac surgery, chronic lung disease, critical preoperative state, presence of insulin dependent diabetes, New York Heart Association (NYHA) classification, Canadian cardiovascular society (CCS) class, left ventricular function, recent myocardial infarction, pulmonary hypertension, urgency and weight of the operation and whether thoracic aorta is involved in surgery.18 Score will be calculated using an online calculator by QxMD website.
Measured: 24 hours before operation
previous associated comorbidities
Diabetes, hypertension, chronic renal failure, liver impairment
Measured: 24 hours before operation
primary pathology
Coronary artery disease, valvular heart disease
Measured: 24 hours before operation
planned operative procedure
Coronary artery bypass graft, valve replacement, Ventricular Septal Defect repair
Measured: 24 hours before operation
liver enzymes
ALT
Measured: 24 hours before operation and 1 hour after operation
sodium level
before and after the operation
Measured: 24 hours before operation and 1 hour after operation
potassium level
before and after the operation
Measured: 24 hours before operation and 1 hour after operation
creatinine
before and after the operation
Measured: 24 hours before operation and 1 hour after operation
urea
before and after the operation
Measured: 24 hours before operation and 1 hour after operation
hemoglobin
before and after the operation
Measured: 24 hours before operation and 1 hour after operation
platelet count
before and after the operation
Measured: 24 hours before operation and 1 hour after operation
prothrombin concentration
before and after the operation
Measured: 24 hours before operation and 1 hour after operation
prothrombin time
before and after the operation
Measured: 24 hours before operation and 1 hour after operation
Cardiopulmonary Bypass (CPB) time
in minutes
Measured: assessed at the end of CBP up to 12 hours from start of operation
Concomitant vasoactive medications
Noradrenaline, adrenaline, dobutamine
Measured: assessed at te end of the operation up to 12 hours from the start of the operation
Arterial blood gas values
baseline after induction , before and after weaning from CBP and postoperatively in critical care with LUS
Measured: assessed up to 24 after the end of operation
Intra and post-operative invasive BP
(invasive BP measured in mmhg
Measured: assessed up to 24 hours postoperatively
Intra and post-operative heart rate
Heart rate measured in beats per minute
Measured: assessed up to 24 hours postoperatively
Postoperative total LUS score
as a sum af all areas assessed by ultrasound
Measured: assessed 12 hours after the end of the operation
individual lung areas score
(Anterior, Lateral and Posterior).
Measured: assessed 12 hours after the end of the operation
extubation time
time from ICU admission till Endotracheal tube removal
Measured: assessed up to 30 days
in-hospital mortality
death before hospital discharge
Measured: until patient discharge assessed up to 30 days
Post-operative complications
Myocardial infarction, atrial fibrillations, Cerebral stroke or bleeding, GI bleeding
Measured: assessed until patient discharge or up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start30 Aug 2020
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
- Investigators
- Mohamed A Hamed, MD, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499027
- Sponsor's protocol ID
- D230
- Status last verified
- Oct 2022
- First submitted
- 26 Jul 2020
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cantinotti M, Giordano R, Volpicelli G, Kutty S, Murzi B, Assanta N, Gargani L. Lung ultrasound in adult and paediatric cardiac surgery: is it time for routine use? Interact Cardiovasc Thorac Surg. 2016 Feb;22(2):208-15. doi: 10.1093/icvts/ivv315. Epub 2015 Nov 18.
PubMed 26586677Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.
PubMed 30372119Bouabdallaoui N, Stevens SR, Doenst T, Petrie MC, Al-Attar N, Ali IS, Ambrosy AP, Barton AK, Cartier R, Cherniavsky A, Demondion P, Desvigne-Nickens P, Favaloro RR, Gradinac S, Heinisch P, Jain A, Jasinski M, Jouan J, Kalil RAK, Menicanti L, Michler RE, Rao V, Smith PK, Zembala M, Velazquez EJ, Al-Khalidi HR, Rouleau JL; STICH Trial Investigators. Society of Thoracic Surgeons Risk Score and EuroSCORE-2 Appropriately Assess 30-Day Postoperative Mortality in the STICH Trial and a Contemporary Cohort of Patients With Left Ventricular Dysfunction Undergoing Surgical Revascularization. Circ Heart Fail. 2018 Nov;11(11):e005531. doi: 10.1161/CIRCHEARTFAILURE.118.005531.
PubMed 30571194Wynne R. Variable definitions: implications for the prediction of pulmonary complications after adult cardiac surgery. Eur J Cardiovasc Nurs. 2004 Apr;3(1):43-52. doi: 10.1016/j.ejcnurse.2003.11.001.
PubMed 15053887Rouby JJ, Arbelot C, Gao Y, Zhang M, Lv J, An Y, Chunyao W, Bin D, Valente Barbas CS, Dexheimer Neto FL, Prior Caltabeloti F, Lima E, Cebey A, Perbet S, Constantin JM; APECHO Study Group. Training for Lung Ultrasound Score Measurement in Critically Ill Patients. Am J Respir Crit Care Med. 2018 Aug 1;198(3):398-401. doi: 10.1164/rccm.201802-0227LE. No abstract available.
PubMed 29557671
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Lung Ultrasound in Predicting Intensive Care Unit Length of Stay in Adult Cardiac Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04499027
- Acronym / sponsor ID
- D230
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Keywords
- Lung ultrasound, coronary artery bypass graft (CABG), open heart surgery, ICU LOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 5 Aug 2020 (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.
Being easy, bedside, non-expensive, noninvasive and radiation free, there has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade, cardiac surgery was not an exception in both adult and pediatric surgeries Many predictors for open heart surgery outcomes have been studied in past years including The Society of Thoracic Surgeons (STS) risk score and the EuroSCORE (ES), preoperative clinical condition, associated chronic diseases, type of surgery, age, duration of cardiopulmonary bypass and brain natriuretic peptide (BNP), cystatin-C A recent study described the use of a novel postoperative lung ultrasound score scanning for B lines which denote subpleural interstitial edema in various lung regions for predicting critical care length of stay in pediatric cardiac surgeries.
The objective of the current study is to evaluate the role of the new lung ultrasound score in predicting the length of postoperative intensive care stay after adult open heart surgeries.
Detailed description
After approval of the local institutional ethics committee and local institutional review board. All patients scheduled for open heart surgery in Fayoum university hospital starting from August 2020 will be enrolled in this prospective observational study until fulfilling sample size. A detailed informed consent will be signed by the eligible participants before recruitment ANESTHETIC TECHNIQUE All patients will be preoperatively assessed and investigated by complete blood count, coagulation profile, Liver and kidney functions and serum electrolytes. Chest X-ray, Electrocardiography (ECG) and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested if needed.
Patient will be premedicated by 10 mg morphine intramuscularly at morning of the operation. Prior to induction of anesthesia, standard monitoring will be applied including a five-lead electrocardiography system, a pulse oximeter probe. A peripheral intravenous (IV) cannula will be placed. An arterial will be inserted using a 20 G cannula either right or left radial artery under local anesthesia. After pre-oxygenation, general anesthesia will be induced using midazolam 2-5 mg, fentanyl (3-10 μg/kg), propofol (1-1.5 mg/Kg), followed by atracurium (0.5 mg/kg).
After trachea intubation, patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. A main stream capnogram, an esophageal temperature probe and a Foley catheter will also be placed. A triple-lumen central venous catheter will be placed usually through the right internal jugular vein.
Maintenance of anesthesia will be achieved by inhaled Isoflurane 0.4 to 1% and atracurium infusion at a rate of 0.5 mg/kg/h. After initiating extracorporeal circulation, Propofol infusion at a rate of 50-100 µg/kg/min will be added to replace isoflurane inhalation.
Patients will receive intravenous heparin (300-500 IU/kg body weight) before the initiation of cardiopulmonary bypass (CPB) to achieve an activated clotting time (ACT) of more than 480 seconds. Cardiopulmonary bypass was instituted with the use of a non-pulsatile blood flow at 2.4 L/min/m2, a non-heparin-coated circuit, and a membrane oxygenator. Mean arterial pressure will be adjusted to exceed 60mmHg before, during and after cardiopulmonary bypass (CBP) . Cardiac arrest will be induced using St Thomas crystalloid solution (Hamburg). Lactated Ringer's solution will be added to the CPB circuit to maintain reservoir volume if needed, and packed red blood cells will be infused when hemoglobin level drops to less than 7g/dl. After rewarming the patient to 37°C and weaning from CPB; Protamine sulfate will be used to reverse the effect of heparin.
After skin closure and wound dressing, patients will be transferred to the intensive care unit intubated with manual ventilation and full monitoring during transfer.
Intensive care Tracheal extubation will be performed when the patient meets the following criteria: awake or arousable, hemodynamically stable, no ongoing active bleeding, warm extremities, no electrolyte abnormalities, no or minimal inotropic support and a satisfactory arterial blood gas with a fraction of inspired oxygen (FiO2) < 0.5, Ventilator pressure support reduced to 10 CmH2O with Positive End Expiratory Pressure (PEEP) 5-7 CmH2O.
ICU management and decisions will be left to the intensivist who is responsible of the postoperative cardiac critical care.
Patient will be discharged from ICU when the following criteria are met: Awake patient with oxygen saturation (SpO2) < 90% at FIO2 > 0.5 by facemask, adequate cardiac stability, no intravenous inotropic or vasopressor supportive therapy, no hemodynamically significant arrhythmia, not dependent on epicardial external pacing no major bleeding i.e. chest tube drainage less than 50 ml/h, urine output of more than 0.5 ml/kg/h and no vital threats to other organ systems such as kidneys and liver.
Lung Ultrasound scan (LUS) All patients will be examined at 12 hours postoperatively as per our institution routine using a convex ultrasound probe, any other LUS will be done upon demand.
LUS will be performed by an experienced radiologist according to standardized protocols.
This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score.
Sample size was calculated using (G power). Minimal sample size of patients was 191 needed to get power level 0.80, alpha level 0.05 (two tailed) and 0.20 as expected β (slope of regression line) for predicting intensive care Length of stay .
Data management will be performed using the Statistical Package for Social Sciences (version 22.0; SPSS Inc., Chicago, IL, USA). Descriptive statistics (mean, standard deviation for quantitative data, and number and percentages for qualitative data) will be used to summarize the data. Nominal data will be analyzed using simple chi squared test, while independent sample t-test or one-way ANOVA procedure will be used to compare means for two or three groups of cases, respectively. Regression analysis will be performed to determine the predictors for LOS. A probability value (P value) ≤ 0.05 is considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted in Fayoum uniersity hospital who are candidates for open heart surgeries
Key inclusion criteria (1 listed)
- all patients Scheduled for elective cardiac surgery for valve replacement, CABG or adult congenital (VSD or ASD) via median sternotomy
Key exclusion criteria (3 listed)
- subjects with inadequate acoustic windows or incomplete examinations (as defined below),
- Patients with emergency surgeries.
- Patients with thoracic deformities or preexisting pulmonary pathology
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 ultrasound scan12 hours postoperatively using a convex ultrasound probe LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior. For each quadrant a score will be assigned based on B lines which are defined as comet like artifacts indicating subpleural interstitial edema as follows: (0) normal aeration: A lines with lung sliding or fewer than two isolated B lines; (1) moderate loss of lung aeration: well-defined, multiple B lines ; (2) severe loss of lung aeration: multiple coalescent B lines; and (3) complete loss of lung aeration or lung consolidation. | Diagnostic test | – |
Primary outcome
Intensive care Length of stay
Time frame: from ICU admission till patient discharge to ward assessed up to 30 days
in days
23 secondary outcomes
EURO Score II
Time frame: 24 hours before operation
previous associated comorbidities
Time frame: 24 hours before operation
primary pathology
Time frame: 24 hours before operation
planned operative procedure
Time frame: 24 hours before operation
liver enzymes
Time frame: 24 hours before operation and 1 hour after operation
sodium level
Time frame: 24 hours before operation and 1 hour after operation
potassium level
Time frame: 24 hours before operation and 1 hour after operation
creatinine
Time frame: 24 hours before operation and 1 hour after operation
urea
Time frame: 24 hours before operation and 1 hour after operation
hemoglobin
Time frame: 24 hours before operation and 1 hour after operation
platelet count
Time frame: 24 hours before operation and 1 hour after operation
prothrombin concentration
Time frame: 24 hours before operation and 1 hour after operation
prothrombin time
Time frame: 24 hours before operation and 1 hour after operation
Cardiopulmonary Bypass (CPB) time
Time frame: assessed at the end of CBP up to 12 hours from start of operation
Concomitant vasoactive medications
Time frame: assessed at te end of the operation up to 12 hours from the start of the operation
Arterial blood gas values
Time frame: assessed up to 24 after the end of operation
Intra and post-operative invasive BP
Time frame: assessed up to 24 hours postoperatively
Intra and post-operative heart rate
Time frame: assessed up to 24 hours postoperatively
Postoperative total LUS score
Time frame: assessed 12 hours after the end of the operation
individual lung areas score
Time frame: assessed 12 hours after the end of the operation
extubation time
Time frame: assessed up to 30 days
in-hospital mortality
Time frame: until patient discharge assessed up to 30 days
Post-operative complications
Time frame: assessed until patient discharge or up to 30 days postoperatively
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 Oct 2022.
- Background: PubMed 26586677Cantinotti M, Giordano R, Volpicelli G, Kutty S, Murzi B, Assanta N, Gargani L. Lung ultrasound in adult and paediatric cardiac surgery: is it time for routine use? Interact Cardiovasc Thorac Surg. 2016 Feb;22(2):208-15. doi: 10.1093/icvts/ivv315. Epub 2015 Nov 18.
- Background: PubMed 30372119Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.
- Background: PubMed 30571194Bouabdallaoui N, Stevens SR, Doenst T, Petrie MC, Al-Attar N, Ali IS, Ambrosy AP, Barton AK, Cartier R, Cherniavsky A, Demondion P, Desvigne-Nickens P, Favaloro RR, Gradinac S, Heinisch P, Jain A, Jasinski M, Jouan J, Kalil RAK, Menicanti L, Michler RE, Rao V, Smith PK, Zembala M, Velazquez EJ, Al-Khalidi HR, Rouleau JL; STICH Trial Investigators. Society of Thoracic Surgeons Risk Score and EuroSCORE-2 Appropriately Assess 30-Day Postoperative Mortality in the STICH Trial and a Contemporary Cohort of Patients With Left Ventricular Dysfunction Undergoing Surgical Revascularization. Circ Heart Fail. 2018 Nov;11(11):e005531. doi: 10.1161/CIRCHEARTFAILURE.118.005531.
- Background: PubMed 15053887Wynne R. Variable definitions: implications for the prediction of pulmonary complications after adult cardiac surgery. Eur J Cardiovasc Nurs. 2004 Apr;3(1):43-52. doi: 10.1016/j.ejcnurse.2003.11.001.
- Background: PubMed 29557671Rouby JJ, Arbelot C, Gao Y, Zhang M, Lv J, An Y, Chunyao W, Bin D, Valente Barbas CS, Dexheimer Neto FL, Prior Caltabeloti F, Lima E, Cebey A, Perbet S, Constantin JM; APECHO Study Group. Training for Lung Ultrasound Score Measurement in Critically Ill Patients. Am J Respir Crit Care Med. 2018 Aug 1;198(3):398-401. doi: 10.1164/rccm.201802-0227LE. No abstract available.
- Euro score IILink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed A Hamed, MD principal investigator
Faculty of medicine, Fayoum university
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 Coronary Artery Disease and Valvular Heart Disease, run by Fayoum University Hospital 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 1 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 19 Oct 2022. 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?
Intensive care Length of stay (time frame: from ICU admission till patient discharge to ward assessed up to 30 days). 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 NCT04499027, which also lists 5 linked publications.
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 Oct 2022.