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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04118621
Other study ID # chest ultrasound after CTS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 1, 2020

Study information

Verified date October 2019
Source Assiut University
Contact Ali Zein Abdelaleim
Phone +201014566896
Email ali_zein2020@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

- assess feasibility of detecting pulmonary complications postoperative using chest ultrasound compared to chest x-ray

- measure time lag between using ultrasound and using chest x-ray to detect pulmonary complications postoperative


Description:

It is well known that cardiothoracic surgery causes different types of pulmonary complications like residual pleural effusion and pneumothorax therefore it is common that surgeons make a thoracic drainage by introducing intercostal tubes for evacuation of air and fluid from the pleural space. Complications extend to involve the parenchymal pulmonary tissue causing consolidation or involve the interstitial tissue .all these complications affect the postoperative recovery.

As a classical technique a daily chest X-ray is performed from first day of surgical intervention to hospital discharge to assess the amount of residual pleural effusion so drainage removal can be done or not and also assess other pulmonary complications.

However, chest X-rays are costly, exposing patients and health care workers to ionizing radiation requiring patient movement with chest drains, difficult positioning of the patient to get good films, and time consuming.

On the other hand, using chest ultrasound is a good alternative for chest X-ray because it is a bedside, easier, more sensitive and accurate in detection of pulmonary complications.

Its main advantages represented in avoiding the danger of ionizing radiations, easier device portability, low cost and a rapid learning curve.

So it is easy and less time consuming to correlate between ultrasound findings and clinical data and assist in invasive procedures.

Hypothesis that detecting pulmonary complications postoperative using chest ultrasound is easier, more sensitive and accurate compared to chest X-ray.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients undergoing cardiothoracic surgery at Assiut University Hospital include CABG, Valve replacement, minimal invasive cardiac surgeries, thoracic surgeries as open thoracotomy and VATS surgeries and others.

- Age >18yrs: 80yrs.

Exclusion Criteria:

- Patients <18yr and >80yrs.

- patient refused to be enrolled in research

- patient with subcutaneous emphysema

Study Design


Intervention

Device:
chest ultrasound
detection of postoperative pulmonary complications after cardiothoracic surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (10)

Amorosa JK, Bramwit MP, Mohammed TL, Reddy GP, Brown K, Dyer DS, Ginsburg ME, Heitkamp DE, Jeudy J, Kirsch J, MacMahon H, Ravenel JG, Saleh AG, Shah RD. ACR appropriateness criteria routine chest radiographs in intensive care unit patients. J Am Coll Radiol. 2013 Mar;10(3):170-4. doi: 10.1016/j.jacr.2012.11.013. — View Citation

Blaivas M, Lyon M, Duggal S. A prospective comparison of supine chest radiography and bedside ultrasound for the diagnosis of traumatic pneumothorax. Acad Emerg Med. 2005 Sep;12(9):844-9. — View Citation

Chung MJ, Goo JM, Im JG, Cho JM, Cho SB, Kim SJ. Value of high-resolution ultrasound in detecting a pneumothorax. Eur Radiol. 2005 May;15(5):930-5. Epub 2004 Dec 18. — View Citation

Goudie E, Bah I, Khereba M, Ferraro P, Duranceau A, Martin J, Thiffault V, Liberman M. Prospective trial evaluating sonography after thoracic surgery in postoperative care and decision making. Eur J Cardiothorac Surg. 2012 May;41(5):1025-30. doi: 10.1093/ejcts/ezr183. Epub 2011 Dec 23. — View Citation

Graham RJ, Meziane MA, Rice TW, Agasthian T, Christie N, Gaebelein K, Obuchowski NA. Postoperative portable chest radiographs: optimum use in thoracic surgery. J Thorac Cardiovasc Surg. 1998 Jan;115(1):45-50; discussion 50-2. — View Citation

Leschber G, May CJ, Simbrey-Chryselius N. [Do thoracic surgery patients always need a postoperative chest X-ray?]. Zentralbl Chir. 2014 Sep;139 Suppl 1:S43-9. doi: 10.1055/s-0034-1383034. Epub 2014 Sep 29. Review. German. — View Citation

Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. — View Citation

Soni NJ, Franco R, Velez MI, Schnobrich D, Dancel R, Restrepo MI, Mayo PH. Ultrasound in the diagnosis and management of pleural effusions. J Hosp Med. 2015 Dec;10(12):811-6. doi: 10.1002/jhm.2434. Epub 2015 Jul 28. Review. — View Citation

Vezzani A, Manca T, Brusasco C, Santori G, Valentino M, Nicolini F, Molardi A, Gherli T, Corradi F. Diagnostic value of chest ultrasound after cardiac surgery: a comparison with chest X-ray and auscultation. J Cardiothorac Vasc Anesth. 2014 Dec;28(6):1527-32. doi: 10.1053/j.jvca.2014.04.012. Epub 2014 Sep 26. — View Citation

Zanobetti M, Poggioni C, Pini R. Can chest ultrasonography replace standard chest radiography for evaluation of acute dyspnea in the ED? Chest. 2011 May;139(5):1140-1147. doi: 10.1378/chest.10-0435. Epub 2010 Oct 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary detecting pulmonary complications postoperative using chest ultrasound compared to chest x-ray assess feasibility of detecting pulmonary complications postoperative using chest ultrasound compared to chest x-ray as chest ultrasound is easier, more sensitive and accurate 1 week
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