Clinical trial NCT05494372: Assessment of Intraoperative Nursing Safety Precautions for Open Heart Surgery Patients on Cardiopulmonary Bypass Machine
Official title: Assessment of Intraoperative Nursing Safety Precautions for Open Heart Surgery Patients on Cardiopulmonary Bypass Machine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nursing Safety on Cardiopulmonary Bypass
Keywords: nursing safety precautions
cardiac surgery
cardiopulmonary bypass machine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: assessment of nursing safety precautions for cardiac surgery patients on cardiopulmonary bypass machine
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
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citation: Jochmans 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.
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