IHDNCT04118621
Role of Chest Ultrasound in Detection of Post-operative Pulmonary Complications After Cardiothoracic Surgery
An observational study of IHD and Valve Heart Disease, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IHD, Valve Heart Disease, Surgery--Complications
- What is being tested?
- chest ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2020
- How long will I take part?
- 1 Week
- 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
- Adult, Older adult
Study population: Patients undergoing cardiothoracic surgery at Assiut University Hospital who meet the listed inclusion, include CABG, Valve replacement, minimal invasive cardiac surgeries, thoracic surgeries as open thoracotomy and VATS surgeries and others
Who may be able to join
- 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.
Who cannot join
- Patients <18yr and >80yrs.
- patient refused to be enrolled in research
- patient with subcutaneous emphysema
Trial locations and contacts
No sites are listed yet.
About this study
- 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
Read the detailed 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.
- Conditions
- IHD, Valve Heart Disease, Surgery--Complications
- Being tested
- chest ultrasound
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest ultrasoundDevice
detection of postoperative pulmonary complications after cardiothoracic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for IHDStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali zein elabdein abd elaleim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118621
- Sponsor's protocol ID
- chest ultrasound after CTS
- Status last verified
- Oct 2019
- First submitted
- 26 Sep 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23571057Graham 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. doi: 10.1016/s0022-5223(98)70441-6.
PubMed 9451044Leschber 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. German.
PubMed 25264723Chung 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. doi: 10.1007/s00330-004-2518-7. Epub 2004 Dec 18.
PubMed 15609058Soni 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.
PubMed 26218493Vezzani 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.
PubMed 25263771Blaivas 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. doi: 10.1197/j.aem.2005.05.005.
PubMed 16141018Zanobetti 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.
PubMed 20947649Goudie 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.
PubMed 22219462Lichtenstein 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. doi: 10.1097/00000542-200401000-00006.
PubMed 14695718
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Chest Ultrasound in Detection of Post-operative Pulmonary Complications After Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT04118621
- Acronym / sponsor ID
- chest ultrasound after CTS
- Conditions
- IHD, Valve Heart Disease, Surgery--Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 8 Oct 2019 (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.
- 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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiothoracic surgery at Assiut University Hospital who meet the listed inclusion, include CABG, Valve replacement, minimal invasive cardiac surgeries, thoracic surgeries as open thoracotomy and VATS surgeries and others
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients <18yr and >80yrs.
- patient refused to be enrolled in research
- patient with subcutaneous emphysema
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 |
|---|---|---|
| chest ultrasounddetection of postoperative pulmonary complications after cardiothoracic surgery | Device | – |
Primary outcome
detecting pulmonary complications postoperative using chest ultrasound compared to chest x-ray
Time frame: 1 week
assess feasibility of detecting pulmonary complications postoperative using chest ultrasound compared to chest x-ray as chest ultrasound is easier, more sensitive and accurate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Background: PubMed 23571057Amorosa 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.
- Background: PubMed 9451044Graham 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. doi: 10.1016/s0022-5223(98)70441-6.
- Background: PubMed 25264723Leschber 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. German.
- Background: PubMed 15609058Chung 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. doi: 10.1007/s00330-004-2518-7. Epub 2004 Dec 18.
- Background: PubMed 26218493Soni 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.
- Background: PubMed 25263771Vezzani 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.
- Background: PubMed 16141018Blaivas 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. doi: 10.1197/j.aem.2005.05.005.
- Background: PubMed 20947649Zanobetti 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.
- Background: PubMed 22219462Goudie 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.
- Background: PubMed 14695718Lichtenstein 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. doi: 10.1097/00000542-200401000-00006.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of IHD and Valve Heart Disease, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Ali Zein Abdelaleim (+201014566896, ali_zein2020@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detecting pulmonary complications postoperative using chest ultrasound compared to chest x-ray (time frame: 1 week). 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 NCT04118621, which also lists 10 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 8 Oct 2019.