Thoracic SurgeryNCT05667467
The Effect of Care Bundle in Heart Surgery
A study testing Care Bundle Implementation in people with Thoracic Surgery and Patient Care Bundles, run by Harran University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Patient Care Bundles
- What is being tested?
- Care Bundle Implementation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2021to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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,
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Care Bundle Implementation on Recovery Process in Open Heart Surgery Patients
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.
Read the detailed description
Introduction: There are several ways to transfer evidence-based practice to the clinic. One of them is "care bundle" implementation.
Purpose: To examine the effect of applying the "Cardiac Surgery Care Bundle" which consists of evidence-based applications, on patients with open heart surgery (AKC) on the quality of recovery and respiratory patterns (respiratory rate, presence of dyspnea, oxygen saturation, etc.). In the study, the compliance status of nurses in the implementation of the care bundle was also examined.
Method:This research is a quasi-experimental, non-randomized study with AKC applied control and study groups. In the study, volunteer nurses working in the surgical intensive care and cardiovascular surgery clinics applied the care bundle created by the researcher to the patients in the study group. care bundle; It includes "Informing the Patients and Their Relatives", "Respiratory Management" and "Early Mobilization" implementations. A total of 103 patients, 69 of whom were control and 34 were study, were included in the study. First, the data of the control group and then the study group were collected. Patients in the control group received standard care, while the study group received a care bundle in addition to the standard care. Data were obtained using the "Descriptive Characteristics Data Form", "Patient Outcomes for Complications Form" and the "Quality of Recovery-40-QoR-40".
Statistical analyses were performed using the IBM SPSS for Windows 22.0 software. The variables were analyzed for normality of distribution using skewness and kurtosis coefficients. Normally distributed variables were presented using mean ± standard deviation values and non-normally distributed variables were presented using median (minimum-maximum) values. Differences between two samples were analyzed using the "Independent Samples t test" when the assumption of normality was met, and using the "Mann-Whitney U" test when the assumption of normality was not met. Categorical variables were analyzed using Chi-square or Fisher's exact tests. Statistical significance was set at p < 0.05.
- Conditions
- Thoracic Surgery, Patient Care Bundles
- Being tested
- Care Bundle Implementation
- Keywords
- Patient care bundles, Nursing, Perioperative nursing, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Bundle ImplementationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Experimental | Not described Receives: Procedure: Care Bundle Implementation |
| NURSE GROUP | Experimental | Not described Receives: Procedure: Care Bundle Implementation |
| STUDY GROUP | Experimental | Not described Receives: Procedure: Care Bundle Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week after surgery
Secondary outcomes (1)
Examination of nurses' compliance with the care bundle
In this study, nurses' compliance rates to the care bundle (application rates to patients) were examined. According to the literature, compliance should be at least 95% in order to have a high level of compliance with the care bundle.
Measured: One week after the data collection process of the study group patients was completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start11 Sep 2021
- Primary completion20 May 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Yılmaz, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667467
- Sponsor's protocol ID
- Harran University
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30426190Engelman 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.
PubMed 31054241Moradian 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.
PubMed 28838589Zanini 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.
PubMed 31343586Myles 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.
PubMed 10740540Buerge 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.
PubMed 32741608Meersch 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.
PubMed 28110412
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Care Bundle Implementation on Recovery Process in Open Heart Surgery Patients
- ClinicalTrials.gov ID
- NCT05667467
- Acronym / sponsor ID
- Harran University
- Conditions
- Thoracic Surgery, Patient Care Bundles
- Keywords
- Patient care bundles, Nursing, Perioperative nursing, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: There are several ways to transfer evidence-based practice to the clinic. One of them is "care bundle" implementation.
Purpose: To examine the effect of applying the "Cardiac Surgery Care Bundle" which consists of evidence-based applications, on patients with open heart surgery (AKC) on the quality of recovery and respiratory patterns (respiratory rate, presence of dyspnea, oxygen saturation, etc.). In the study, the compliance status of nurses in the implementation of the care bundle was also examined.
Method:This research is a quasi-experimental, non-randomized study with AKC applied control and study groups. In the study, volunteer nurses working in the surgical intensive care and cardiovascular surgery clinics applied the care bundle created by the researcher to the patients in the study group. care bundle; It includes "Informing the Patients and Their Relatives", "Respiratory Management" and "Early Mobilization" implementations. A total of 103 patients, 69 of whom were control and 34 were study, were included in the study. First, the data of the control group and then the study group were collected. Patients in the control group received standard care, while the study group received a care bundle in addition to the standard care. Data were obtained using the "Descriptive Characteristics Data Form", "Patient Outcomes for Complications Form" and the "Quality of Recovery-40-QoR-40".
Statistical analyses were performed using the IBM SPSS for Windows 22.0 software. The variables were analyzed for normality of distribution using skewness and kurtosis coefficients. Normally distributed variables were presented using mean ± standard deviation values and non-normally distributed variables were presented using median (minimum-maximum) values. Differences between two samples were analyzed using the "Independent Samples t test" when the assumption of normality was met, and using the "Mann-Whitney U" test when the assumption of normality was not met. Categorical variables were analyzed using Chi-square or Fisher's exact tests. Statistical significance was set at p < 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Experimental | Procedure: Care Bundle Implementation |
| NURSE GROUP | Experimental | Procedure: Care Bundle Implementation |
| STUDY GROUP | Experimental | Procedure: Care Bundle Implementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
Key exclusion criteria (10 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Bundle ImplementationIn 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. | Procedure or surgery | CONTROL GROUP, NURSE GROUP, STUDY GROUP |
Primary outcome
The effect of the care bundle on the recovery status of the patients
Time frame: One week after surgery
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.
1 secondary outcome
Examination of nurses' compliance with the care bundle
Time frame: One week after the data collection process of the study group patients was completed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Background: PubMed 30426190Gustafsson 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.
- Background: PubMed 31054241Engelman 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.
- Background: PubMed 28838589Moradian 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.
- Background: PubMed 31343586Zanini 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.
- Background: PubMed 10740540Myles 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.
- Background: PubMed 32741608Buerge 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.
- Background: PubMed 28110412Meersch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Bundle Implementation in people with Thoracic Surgery and Patient Care Bundles, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of the care bundle on the recovery status of the patients (time frame: One week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05667467, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.