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

August 9, 2022 updated by: Shimaa Taha Badwy, Assiut University
Assessment of intraoperative nursing safety precautions for open heart surgery patients on cardiopulmonary bypass machine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shimaa Taha Badwy, nursing specialist
  • Phone Number: 0882463272 01113831332
  • Email: Shimaat494@gmail.com

Study Contact Backup

  • Name: Mona Aly Mohammed, assistant professor
  • Phone Number: 0882347821 0122614645
  • Email: mona@aun.edu.eg

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Faculty of Nursing
        • Contact:
        • Contact:
          • mona aly mohammed, Assistant professor
          • Phone Number: 2347821 01226164645
          • Email: mona@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2021

Primary Completion (Anticipated)

September 10, 2022

Study Completion (Anticipated)

October 15, 2022

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nursing safety on CBP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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