Nursing Safety on Cardiopulmonary BypassNCT05494372
Assessment of Intraoperative Nursing Safety Precautions for Open Heart Surgery Patients on Cardiopulmonary Bypass Machine
An observational study of Nursing Safety on Cardiopulmonary Bypass, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of intraoperative nursing safety precautions for open heart surgery patients on cardiopulmonary bypass machine. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Safety on Cardiopulmonary Bypass
- What is being tested?
- safety precautions
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2021to 15 Oct 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Convenient sample of 60 adult male and female patients who presented to cardiothoracic unit for undergoing cardiac surgery using cardiopulmonary bypass machine were included in addition to 20 critical care nurses acts as a perfusionist who are willing to participate in the study.
Who may be able to join
- Aged 18-60years.
- Coronary artery bypass grafting patients.
- Aortic valve replacement/repair patients.
- Mitral valve replacement/repair patients.
- Tricuspid valve replacement/repair patients.
- In addition to critical care nurses whom are also willing to participate in this study.
Who cannot join
- The exclusion criteria are as follow:
- patients with previous open-heart surgery.
- Patients with high bleeding tendency.
- patients with associated aneurysm of the left ventricle or ischemic VSD defect with recent cardiac infarction.
- patients with liver cell failure.
- Patients with renal failure on regular dialysis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing
Asyut
Naglaa Ahmed Ahmed, Assistant professor, 01151274745 ext. 234665, dr.naglaacritical@aun.edu.eg
mona aly mohammed, Assistant professor, 01226164645 ext. 2347821, mona@aun.edu.eg
About this study
Assessment of intraoperative nursing safety precautions for open heart surgery patients on cardiopulmonary bypass machine.
Read the detailed description
Coronary artery bypass grafts surgery (CABG) can be performed either with cardiopulmonary bypass (CPB), which exposes the blood to a non-physiological environment, or on beating heart without CPB support. One of the most challenging aspects of coronary artery bypass grafting surgery is the management of high-risk patients and management of possible complications due to cardiopulmonary bypass machine to achieve acceptable morbidity, mortality, and quality of life Nursing safety precautions during cardiopulmonary bypass surgery begins with the perfusionists and critical care nurses experience and knowledge of all the possible errors that may occur. This knowledge fosters the anticipation of problems and promotes vigilance safety precautions for prevention of possible complications which may occur as a result of cardiopulmonary bypass machine.
Advances in cardiac surgery have been possible due to the development of cardiopulmonary bypass machine. Cardiopulmonary bypass machine is a form of extracorporeal circulation whose function is circulatory and respiratory support along with temperature management to facilitate surgery on the heart and great vessels. The first successful human cardiac surgery using CPB was performed by John Gibbon in 1952 for repair of the atrial septal defect. Complications that occur as a result of cardiopulmonary bypass machine in cardiac surgery patients includes mechanical and systemic complications, mechanical complications such as bleeding, oxygenator failure, pump malfunction, clotting in the circuit, tubing rupture, gas supply failure and electrical failure. Systemic complications include qualitative and quantitative platelet dysfunction. Inflammatory response and hypotension can cause acute kidney injury. Risk factors are prolonged bypass time, sepsis and diabetes. cerebral injury ranges from cognitive dysfunction to stroke. Acute respiratory distress syndrome can be present due to the effects of CPB.
Nursing safety precautions related to cardiac surgery with cardiopulmonary bypass machine were written with collaboration from the Society of Cardiovascular Anesthesiologists, and an update to these safety precautions that have collaborated on nursing safety precautions for anticoagulation, as Clotting on cardiopulmonary bypass is life-threatening. Temperature management, acid base balance management, monitoring on cardiopulmonary bypass, ultra-filtration during and after CPB removes inflammatory mediators and weaning management. These safety precautions provide professional nurses with actionable evidence informed by expert opinion, to achieve acceptable morbidity, mortality, and quality of life.
- Conditions
- Nursing Safety on Cardiopulmonary Bypass
- Being tested
- safety precautions
- Keywords
- nursing safety precautions, cardiac surgery, cardiopulmonary bypass machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safety precautionsOther
Nursing safety precautions on CPB
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of nursing safety precautions for cardiac surgery patients on cardiopulmonary bypass machine
- This part was including assessment of nursing safety precautions during surgery for patients on cardiopulmonary bypass machine using scoring system.
- Nursing safety precautions consists of four main items each item divided into steps, each step takes a score ranging from 0 to 2, minimum score is 0 (not apply), medium score is1 (need improve) and maximum score is 2 (well done).
- Total steps in four items are 45 steps their total score is 90, scoring system transformed into percent:( < 85% unsatisfactory), (>= 85% satisfactory).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start4 Sep 2021
- Primary completion10 Sep 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nursing Safety on Cardiopulmonary BypassStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Taha Badwy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494372
- Sponsor's protocol ID
- Nursing safety on CBP
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rijkse E, de Jonge J, Kimenai HJAN, Hoogduijn MJ, de Bruin RWF, van den Hoogen MWF, IJzermans JNM, Minnee RC. Safety and feasibility of 2 h of normothermic machine perfusion of donor kidneys in the Eurotransplant Senior Program. BJS Open. 2021 Jan 8;5(1):zraa024. doi: 10.1093/bjsopen/zraa024.
PubMed 33609374Jochmans I, Brat A, Davies L, Hofker HS, van de Leemkolk FEM, Leuvenink HGD, Knight SR, Pirenne J, Ploeg RJ; COMPARE Trial Collaboration and Consortium for Organ Preservation in Europe (COPE). Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial. Lancet. 2020 Nov 21;396(10263):1653-1662. doi: 10.1016/S0140-6736(20)32411-9.
PubMed 33220737Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.
PubMed 28970635Wang X, Zhang J, Feng K, Yang Y, Qi W, Martinez-Vazquez P, Zhao G, Wang T. The effect of hypothermia during cardiopulmonary bypass on three electro-encephalographic indices assessing analgesia and hypnosis during anesthesia: consciousness index, nociception index, and bispectral index. Perfusion. 2020 Mar;35(2):154-162. doi: 10.1177/0267659119864821. Epub 2019 Aug 7.
PubMed 31387454
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intraoperative Nursing Safety Precautions for Open Heart Surgery Patients on Cardiopulmonary Bypass Machine
- ClinicalTrials.gov ID
- NCT05494372
- Acronym / sponsor ID
- Nursing safety on CBP
- Conditions
- Nursing Safety on Cardiopulmonary Bypass
- Keywords
- nursing safety precautions, cardiac surgery, cardiopulmonary bypass machine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 10 Sep 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 10 Aug 2022 (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.
Assessment of intraoperative nursing safety precautions for open heart surgery patients on cardiopulmonary bypass machine.
Detailed description
Coronary artery bypass grafts surgery (CABG) can be performed either with cardiopulmonary bypass (CPB), which exposes the blood to a non-physiological environment, or on beating heart without CPB support. One of the most challenging aspects of coronary artery bypass grafting surgery is the management of high-risk patients and management of possible complications due to cardiopulmonary bypass machine to achieve acceptable morbidity, mortality, and quality of life Nursing safety precautions during cardiopulmonary bypass surgery begins with the perfusionists and critical care nurses experience and knowledge of all the possible errors that may occur. This knowledge fosters the anticipation of problems and promotes vigilance safety precautions for prevention of possible complications which may occur as a result of cardiopulmonary bypass machine.
Advances in cardiac surgery have been possible due to the development of cardiopulmonary bypass machine. Cardiopulmonary bypass machine is a form of extracorporeal circulation whose function is circulatory and respiratory support along with temperature management to facilitate surgery on the heart and great vessels. The first successful human cardiac surgery using CPB was performed by John Gibbon in 1952 for repair of the atrial septal defect. Complications that occur as a result of cardiopulmonary bypass machine in cardiac surgery patients includes mechanical and systemic complications, mechanical complications such as bleeding, oxygenator failure, pump malfunction, clotting in the circuit, tubing rupture, gas supply failure and electrical failure. Systemic complications include qualitative and quantitative platelet dysfunction. Inflammatory response and hypotension can cause acute kidney injury. Risk factors are prolonged bypass time, sepsis and diabetes. cerebral injury ranges from cognitive dysfunction to stroke. Acute respiratory distress syndrome can be present due to the effects of CPB.
Nursing safety precautions related to cardiac surgery with cardiopulmonary bypass machine were written with collaboration from the Society of Cardiovascular Anesthesiologists, and an update to these safety precautions that have collaborated on nursing safety precautions for anticoagulation, as Clotting on cardiopulmonary bypass is life-threatening. Temperature management, acid base balance management, monitoring on cardiopulmonary bypass, ultra-filtration during and after CPB removes inflammatory mediators and weaning management. These safety precautions provide professional nurses with actionable evidence informed by expert opinion, to achieve acceptable morbidity, mortality, and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Convenient sample of 60 adult male and female patients who presented to cardiothoracic unit for undergoing cardiac surgery using cardiopulmonary bypass machine were included in addition to 20 critical care nurses acts as a perfusionist who are willing to participate in the study.
Key inclusion criteria (6 listed)
- Aged 18-60years.
- Coronary artery bypass grafting patients.
- Aortic valve replacement/repair patients.
- Mitral valve replacement/repair patients.
- Tricuspid valve replacement/repair patients.
Key exclusion criteria (6 listed)
- patients with previous open-heart surgery.
- Patients with high bleeding tendency.
- patients with associated aneurysm of the left ventricle or ischemic VSD defect with recent cardiac infarction.
- patients with liver cell failure.
- Patients with renal failure on regular dialysis.
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 |
|---|---|---|
| safety precautionsNursing safety precautions on CPB | Other | – |
Primary outcome
assessment of nursing safety precautions for cardiac surgery patients on cardiopulmonary bypass machine
Time frame: baseline
* This part was including assessment of nursing safety precautions during surgery for patients on cardiopulmonary bypass machine using scoring system. * Nursing safety precautions consists of four main items each item divided into steps, each step takes a score ranging from 0 to 2, minimum score is 0 (not apply), medium score is1 (need improve) and maximum score is 2 (well done). * Total steps in four items are 45 steps their total score is 90, scoring system transformed into percent:( < 85% unsatisfactory), (>= 85% satisfactory).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Background: PubMed 33609374Rijkse E, de Jonge J, Kimenai HJAN, Hoogduijn MJ, de Bruin RWF, van den Hoogen MWF, IJzermans JNM, Minnee RC. Safety and feasibility of 2 h of normothermic machine perfusion of donor kidneys in the Eurotransplant Senior Program. BJS Open. 2021 Jan 8;5(1):zraa024. doi: 10.1093/bjsopen/zraa024.
- Background: PubMed 33220737Jochmans I, Brat A, Davies L, Hofker HS, van de Leemkolk FEM, Leuvenink HGD, Knight SR, Pirenne J, Ploeg RJ; COMPARE Trial Collaboration and Consortium for Organ Preservation in Europe (COPE). Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial. Lancet. 2020 Nov 21;396(10263):1653-1662. doi: 10.1016/S0140-6736(20)32411-9.
- Background: PubMed 28970635Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.
- Background: PubMed 31387454Wang X, Zhang J, Feng K, Yang Y, Qi W, Martinez-Vazquez P, Zhao G, Wang T. The effect of hypothermia during cardiopulmonary bypass on three electro-encephalographic indices assessing analgesia and hypnosis during anesthesia: consciousness index, nociception index, and bispectral index. Perfusion. 2020 Mar;35(2):154-162. doi: 10.1177/0267659119864821. Epub 2019 Aug 7.
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.
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 Nursing Safety on Cardiopulmonary Bypass, run by Assiut University 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 6 inclusion and 6 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 11 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Taha Badwy, nursing specialist (01113831332 ext. 0882463272, Shimaat494@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of nursing safety precautions for cardiac surgery patients on cardiopulmonary bypass machine (time frame: baseline). 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 NCT05494372, which also lists 4 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 11 Aug 2022.