AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in Egypt

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.

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.

  1. Intensive care Length of stay

    in days

    Measured: from ICU admission till patient discharge to ward assessed up to 30 days

Secondary outcomes (23)
  1. 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

  2. previous associated comorbidities

    Diabetes, hypertension, chronic renal failure, liver impairment

    Measured: 24 hours before operation

  3. primary pathology

    Coronary artery disease, valvular heart disease

    Measured: 24 hours before operation

  4. planned operative procedure

    Coronary artery bypass graft, valve replacement, Ventricular Septal Defect repair

    Measured: 24 hours before operation

  5. liver enzymes

    ALT

    Measured: 24 hours before operation and 1 hour after operation

  6. sodium level

    before and after the operation

    Measured: 24 hours before operation and 1 hour after operation

  7. potassium level

    before and after the operation

    Measured: 24 hours before operation and 1 hour after operation

  8. creatinine

    before and after the operation

    Measured: 24 hours before operation and 1 hour after operation

  9. urea

    before and after the operation

    Measured: 24 hours before operation and 1 hour after operation

  10. hemoglobin

    before and after the operation

    Measured: 24 hours before operation and 1 hour after operation

  11. platelet count

    before and after the operation

    Measured: 24 hours before operation and 1 hour after operation

  12. prothrombin concentration

    before and after the operation

    Measured: 24 hours before operation and 1 hour after operation

  13. prothrombin time

    before and after the operation

    Measured: 24 hours before operation and 1 hour after operation

  14. Cardiopulmonary Bypass (CPB) time

    in minutes

    Measured: assessed at the end of CBP up to 12 hours from start of operation

  15. Concomitant vasoactive medications

    Noradrenaline, adrenaline, dobutamine

    Measured: assessed at te end of the operation up to 12 hours from the start of the operation

  16. 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

  17. Intra and post-operative invasive BP

    (invasive BP measured in mmhg

    Measured: assessed up to 24 hours postoperatively

  18. Intra and post-operative heart rate

    Heart rate measured in beats per minute

    Measured: assessed up to 24 hours postoperatively

  19. Postoperative total LUS score

    as a sum af all areas assessed by ultrasound

    Measured: assessed 12 hours after the end of the operation

  20. individual lung areas score

    (Anterior, Lateral and Posterior).

    Measured: assessed 12 hours after the end of the operation

  21. extubation time

    time from ICU admission till Endotracheal tube removal

    Measured: assessed up to 30 days

  22. in-hospital mortality

    death before hospital discharge

    Measured: until patient discharge assessed up to 30 days

  23. 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.

  1. First posted5 Aug 2020
  2. Study start30 Aug 2020
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Resources

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)
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 26586677
  • Mojoli 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 30372119
  • Bouabdallaoui 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 30571194
  • Wynne 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 15053887
  • Rouby 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in