NCT05667467

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

December 7, 2022

Last Update Submit

December 19, 2022

Conditions

Keywords

Patient care bundlesNursingPerioperative nursingCardiac surgery

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

EXPERIMENTAL
Procedure: Care Bundle Implementation

NURSE GROUP

EXPERIMENTAL
Procedure: Care Bundle Implementation

STUDY GROUP

EXPERIMENTAL
Procedure: Care Bundle Implementation

Interventions

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.

CONTROL GROUPNURSE GROUPSTUDY GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 30426190BACKGROUND
  • Engelman 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: 31054241BACKGROUND
  • Moradian 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: 28838589BACKGROUND
  • Zanini 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: 31343586BACKGROUND
  • Myles 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: 10740540BACKGROUND
  • Buerge 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: 32741608BACKGROUND
  • Meersch 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

Locations