The Effect of Care Bundle in Heart Surgery
Investigation of the Effect of Care Bundle Implementation on Recovery Process in Open Heart Surgery Patients
1 other identifier
interventional
103
1 country
1
Brief Summary
This study is a quasi-experimental (non-randomized) design study with control and study group patients undergoing open heart surgery. The main purpose of the research to examine the effect of the care bundle application on the quality of recovery and respiratory patterns (respiratory rate, presence of dyspnea, oxygen saturation, etc.) in patients with open heart surgery. The other purpose is examine the compliance rates of nurses in the implementation of the cardiac surgery care bundle on patients. In the study, nurses working in the cardiovascular surgery clinic and surgical intensive care unit in a training and research hospital in southeast Turkey voluntarily applied the care bundle created by the researcher to the patients in the study group. When the data of the study were examined, it was seen that the respiratory patterns and recovery status of the patients who received the care bundle were better. However, it was determined that the compliance rate of the nurses to the care bundle was not at the desired level.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2022
CompletedFirst Submitted
Initial submission to the registry
December 7, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedDecember 28, 2022
December 1, 2022
8 months
December 7, 2022
December 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of the care bundle on the recovery status of the patients
In the study, the recovery status of patients after surgery was measured with the "Recovery Quality-40 Questionnaire". The contribution of the cardiac surgery care bundle applied to the study group by the clinical nurses to the recovery status was examined.
One week after surgery
Secondary Outcomes (1)
Examination of nurses' compliance with the care bundle
One week after the data collection process of the study group patients was completed.
Study Arms (3)
CONTROL GROUP
EXPERIMENTALNURSE GROUP
EXPERIMENTALSTUDY GROUP
EXPERIMENTALInterventions
In this study, the control group received standard care. The nurse group was given training on the implementation of the care bundle. A "cardiac surgery care bundle" was applied to the study group by clinical nurses.
Eligibility Criteria
You may qualify if:
- years and older,
- Elective AKC planned
- Those who will undergo cardiac surgery for the first time
- Extubated after cardiac surgery and not given sedating drugs
- No communication barrier (including hearing and vision problems),
- Does not have a musculoskeletal disease or neurological problem that will prevent walking after surgery,
- Does not have any respiratory disease,
- Psychiatric, not diagnosed with mental illness,
- Those who volunteered to participate in the research
- Patients who are 18 years of age or older who volunteer to participate in the research.
- Working as a nurse in cardiovascular surgery clinic or surgical intensive care clinic,
- It is the nurses who volunteer to participate in the research.
You may not qualify if:
- Patients with active bleeding after surgery
- Developing neurological complications
- Complications that prevent the patient from standing up after surgery
- Those with respiratory problems that will delay weaning from the mechanical ventilator
- Re-operated due to the development of any complication
- Those who want to leave the research during the pre- or post-surgical research process
- These are the patients who develop a situation where they cannot continue to accompany the patient while they are accompanying the patient, or who are the relatives of the patients who want to leave the research during the research process.
- Assigned to another clinic during the research process,
- Resigned from his job during the research process,
- Nurses who want to leave the study during any phase of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yasemin Yılmaz
Sanliurfa, Haliliye, Turkey (Türkiye)
Related Publications (7)
Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
PMID: 30426190BACKGROUNDEngelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
PMID: 31054241BACKGROUNDMoradian ST, Najafloo M, Mahmoudi H, Ghiasi MS. Early mobilization reduces the atelectasis and pleural effusion in patients undergoing coronary artery bypass graft surgery: A randomized clinical trial. J Vasc Nurs. 2017 Sep;35(3):141-145. doi: 10.1016/j.jvn.2017.02.001.
PMID: 28838589BACKGROUNDZanini M, Nery RM, de Lima JB, Buhler RP, da Silveira AD, Stein R. Effects of Different Rehabilitation Protocols in Inpatient Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery: A RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2019 Nov;39(6):E19-E25. doi: 10.1097/HCR.0000000000000431.
PMID: 31343586BACKGROUNDMyles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PMID: 10740540BACKGROUNDBuerge M, Magboo R, Wills D, Karpouzis I, Balmforth D, Cooper P, Roberts N, O'Brien B. Doing Simple Things Well: Practice Advisory Implementation Reduces Atrial Fibrillation After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2913-2920. doi: 10.1053/j.jvca.2020.06.078. Epub 2020 Jul 3.
PMID: 32741608BACKGROUNDMeersch M, Schmidt C, Hoffmeier A, Van Aken H, Wempe C, Gerss J, Zarbock A. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1551-1561. doi: 10.1007/s00134-016-4670-3. Epub 2017 Jan 21.
PMID: 28110412BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
December 7, 2022
First Posted
December 28, 2022
Study Start
September 11, 2021
Primary Completion
May 20, 2022
Study Completion
June 24, 2022
Last Updated
December 28, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share