NCT04499027

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

August 30, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

1.9 years

First QC Date

July 26, 2020

Last Update Submit

October 18, 2022

Conditions

Coronary Artery DiseaseValvular Heart Disease

Keywords

Lung ultrasoundcoronary artery bypass graft (CABG)open heart surgeryICU LOS

Outcome Measures

Primary Outcomes (1)

  • Intensive care Length of stay

    in days

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

Secondary Outcomes (23)

  • EURO Score II

    24 hours before operation

  • previous associated comorbidities

    24 hours before operation

  • primary pathology

    24 hours before operation

  • planned operative procedure

    24 hours before operation

  • liver enzymes

    24 hours before operation and 1 hour after operation

  • +18 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted in Fayoum uniersity hospital who are candidates for open heart surgeries

You may qualify if:

  • all patients Scheduled for elective cardiac surgery for valve replacement, CABG or adult congenital (VSD or ASD) via median sternotomy

You may not qualify if:

  • subjects with inadequate acoustic windows or incomplete examinations (as defined below),
  • Patients with emergency surgeries.
  • Patients with thoracic deformities or preexisting pulmonary pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 26586677BACKGROUND

  • 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.

    PMID: 30372119BACKGROUND

  • 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.

    PMID: 30571194BACKGROUND

  • 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.

    PMID: 15053887BACKGROUND

  • 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.

    PMID: 29557671BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mohamed A Hamed, MD

    Faculty of medicine, Fayoum university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Amesthesiology

Study Record Dates

First Submitted

July 26, 2020

First Posted

August 5, 2020

Study Start

August 30, 2020

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

EG(1)