Assessment of Intraoperative Nursing Safety Precautions for Open Heart Surgery Patients on Cardiopulmonary Bypass Machine

NCT ID: NCT05494372

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-04

Study Completion Date

2022-10-15

Brief Summary

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Assessment of intraoperative nursing safety precautions for open heart surgery patients on cardiopulmonary bypass machine.

Detailed Description

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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

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Nursing Safety on Cardiopulmonary Bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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safety precautions

Nursing safety precautions on CPB

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Taha Badwy

Head of nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Nursing

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shimaa Taha Badwy, nursing specialist

Role: CONTACT

01113831332 ext. 0882463272

Mona Aly Mohammed, assistant professor

Role: CONTACT

0122614645 ext. 0882347821

Facility Contacts

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Naglaa Ahmed Ahmed, Assistant professor

Role: primary

01151274745 ext. 234665

mona aly mohammed, Assistant professor

Role: backup

01226164645 ext. 2347821

References

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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.

Reference Type BACKGROUND
PMID: 33609374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33220737 (View on PubMed)

Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.

Reference Type BACKGROUND
PMID: 28970635 (View on PubMed)

Wang 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.

Reference Type BACKGROUND
PMID: 31387454 (View on PubMed)

Other Identifiers

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Nursing safety on CBP

Identifier Type: -

Identifier Source: org_study_id

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