Delirium, PostoperativeNCT06268119
Effectiveness of Delirium Care Protocol After Cardiac Surgery
A study testing training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium. in people with Delirium, Postoperative, run by Gonul Kara Soylemez at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium, Postoperative
- What is being tested?
- training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2023to 22 May 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study,
- Being 18 years or older,
- Ability to speak and communicate in Turkish,
- Having undergone cardiac surgery and being on the first postoperative day,
- Richmond Agitation and Sedation Scale (RASS) score of -3 and above,
- Having a Glasgow Coma Scale (GCS) score of 8 and above,
- Not having a serious psychiatric or neurological diagnosis,
- No serious visual or auditory problems
Who cannot join
- Undergoing surgeries other than cardiac surgery (such as abdominal endovascular aneurysm repair, thoracic endovascular aneurysm repair, deep vein thrombosis, peripheral artery disease, carotid endarterectomy),
- Previous cardiac surgery,
- Postponing or canceling the surgery,
- No preoperative admission to the cardiovascular surgery service and no emergency surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, Center, 07000
About this study
Official title: Effectiveness of Postoperative Delirium Prevention, Diagnosis and Intervention Protocol on Patients Monitored in the Intensive Care Unit After Cardiac Surgery
This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery.
Read the detailed description
This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. The research was conducted at Antalya Training and Research Hospital between 06.03.2023 and 22.05.2023. The sample of the study consisted of 64 patients who underwent cardiac surgery and met the inclusion criteria. Within the scope of the study, patients were divided into two groups: control (32) and intervention (32). While the patients in the intervention group received care in line with the "Postoperative delirium prevention, diagnosis and intervention protocol", the patients in the control group received routine nursing care for delirium. The data of the study were collected using the Patient Identification Form, Acute Physiological and Chronic Health Evaluation, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Confusion Assessment Scale in the Intensive Care Unit, Nurse Diagnosis Form, Information Assessment Form for Postoperative Delirium (Pretest-Posttest) and Postoperative Delirium Prevention, Diagnosis and Intervention Protocol Checklist. In the first stage of the study, which consisted of three stages, the incidence of delirium in the control group patients receiving routine nursing care and the delirium diagnosis status of the nurses were determined. In the second stage, nurses were given training on postoperative delirium prevention, diagnosis and intervention protocol, and a preliminary study of the protocol was conducted. In the third phase, which is the last phase, patients in the intervention group received care in line with the "Postoperative Delirium Prevention, Diagnosis and Intervention Protocol".
- Conditions
- Delirium, Postoperative
- Being tested
- training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.
- Keywords
- delirium, cardiac surgery, nursing
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.Other
The intervention group received care in line with the postoperative delirium prevention, diagnosis and intervention protocol after the delirium training given by the researcher to intensive care unit nurses.
| Study group | Role | What they receive |
|---|---|---|
| Control group (standard clinical care) | No intervention | Control group receiving standard care administered by doctors and nurses for delirium management in the intensive care unit |
| Intervention group (care with protocol) | Experimental | The intervention group received care in line with the postoperative delirium prevention, diagnosis and intervention protocol after the delirium training given by the researcher to intensive care unit nurses. Receives: Other: training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU)
With the application of CAM-ICU, an evaluation is made as "there is delirium" or "there is no delirium". CAM-ICU; It consists of four items including sudden change of consciousness or fluctuation in the patient's level of consciousness, attention assessment, and evaluation of thought organization and level of consciousness. According to this scale, in order for patients to be diagnosed with delirium, the first and second items and one of the third or fourth items must result in favor of delirium.
Measured: Three weeks
Secondary outcomes (3)
Glasgow Coma Scale (GCS)
It is used to evaluate the patients' state of consciousness. With a scale consisting of three parts: eye opening, motor and verbal response, the patients' response to stimuli in these three areas is evaluated and scored. It is evaluated between three and fifteen points, with fifteen points indicating full consciousness and three points indicating deep coma. In order for CAM-ICU to be applied to patients, the GCS score must be eight or above. If the GCS score is eight or below, the patient is considered to be in a coma and cannot be evaluated.
Measured: Three weeks
Richmond Agitation-Sedation Scale (RASS)
Before starting the delirium evaluation, the state of consciousness (alertness) is first evaluated. RASS takes values between "(+4)" and "(-5)". While the ideal level where the patient is alert and calm is scored as "0" on the scale, positive RASS scores "(+1,+2,+3,+4)" indicate an agitated patient; Negative RASS scores "(-1,-2,-3,-4,-5)" indicate patients who are sedated or in a coma.
Measured: Three weeks
Information Assessment Form for Postoperative Delirium (Pretest-Posttest)
The knowledge assessment form for postoperative delirium (Pretest-Posttest) was developed by researchers by scanning the literature in order to measure the knowledge levels of nurses working in intensive care units before and after training on postoperative delirium. For each item in the form consisting of 30 questions, answers were received from the participants as "True", "False" and "I don't know". "1" point was given for each "True" statement, and "0" point was given for each "False" and "I don't know" statements. The highest score that can be obtained from the test is "30". The form, consisting of items regarding the definition of delirium, risk factors, symptoms, prevention, diagnosis and intervention of delirium, was applied by the researcher to all nurses who attended the training before and after the training.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start6 Mar 2023
- Primary completion15 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Delirium, PostoperativeStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonul Kara Soylemez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gonul Kara Soylemez, Mustafa Kemal University
- Investigators
- Gonul Kara Soylemez, MD, Principal investigator, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268119
- Sponsor's protocol ID
- MustafaKU-SBF-GKS-01
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
PubMed 11445689Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
PubMed 12421743Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
PubMed 28187050Allen SR, Frankel HL. Postoperative complications: delirium. Surg Clin North Am. 2012 Apr;92(2):409-31, x. doi: 10.1016/j.suc.2012.01.012.
PubMed 22414419Hshieh TT, Inouye SK, Oh ES. Delirium in the Elderly. Clin Geriatr Med. 2020 May;36(2):183-199. doi: 10.1016/j.cger.2019.11.001.
PubMed 32222295Soylemez GK, Bulut H. The effectiveness of postoperative delirium prevention, diagnosis, and intervention protocol in patients monitored in the intensive care unit after cardiac surgery: a quasi-experimental study. BMC Nurs. 2024 Dec 18;23(1):904. doi: 10.1186/s12912-024-02547-y.
PubMed 39695628
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Postoperative Delirium Prevention, Diagnosis and Intervention Protocol on Patients Monitored in the Intensive Care Unit After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06268119
- Acronym / sponsor ID
- MustafaKU-SBF-GKS-01
- Conditions
- Delirium, Postoperative
- Keywords
- delirium, cardiac surgery, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gonul Kara SoylemezUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 20 Feb 2024 (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 was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery.
Detailed description
This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. The research was conducted at Antalya Training and Research Hospital between 06.03.2023 and 22.05.2023. The sample of the study consisted of 64 patients who underwent cardiac surgery and met the inclusion criteria. Within the scope of the study, patients were divided into two groups: control (32) and intervention (32). While the patients in the intervention group received care in line with the "Postoperative delirium prevention, diagnosis and intervention protocol", the patients in the control group received routine nursing care for delirium. The data of the study were collected using the Patient Identification Form, Acute Physiological and Chronic Health Evaluation, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Confusion Assessment Scale in the Intensive Care Unit, Nurse Diagnosis Form, Information Assessment Form for Postoperative Delirium (Pretest-Posttest) and Postoperative Delirium Prevention, Diagnosis and Intervention Protocol Checklist. In the first stage of the study, which consisted of three stages, the incidence of delirium in the control group patients receiving routine nursing care and the delirium diagnosis status of the nurses were determined. In the second stage, nurses were given training on postoperative delirium prevention, diagnosis and intervention protocol, and a preliminary study of the protocol was conducted. In the third phase, which is the last phase, patients in the intervention group received care in line with the "Postoperative Delirium Prevention, Diagnosis and Intervention Protocol".
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention.
| Arm | Type | Receives |
|---|---|---|
| Control group (standard clinical care) | No intervention | –Control group receiving standard care administered by doctors and nurses for delirium management in the intensive care unit |
| Intervention group (care with protocol) | Experimental | Other: training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.The intervention group received care in line with the postoperative delirium prevention, diagnosis and intervention protocol after the delirium training given by the researcher to intensive care unit nurses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteering to participate in the study,
- Being 18 years or older,
- Ability to speak and communicate in Turkish,
- Having undergone cardiac surgery and being on the first postoperative day,
- Richmond Agitation and Sedation Scale (RASS) score of -3 and above,
Key exclusion criteria (4 listed)
- Undergoing surgeries other than cardiac surgery (such as abdominal endovascular aneurysm repair, thoracic endovascular aneurysm repair, deep vein thrombosis, peripheral artery disease, carotid endarterectomy),
- Previous cardiac surgery,
- Postponing or canceling the surgery,
- No preoperative admission to the cardiovascular surgery service and no emergency surgery.
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 |
|---|---|---|
| training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.The intervention group received care in line with the postoperative delirium prevention, diagnosis and intervention protocol after the delirium training given by the researcher to intensive care unit nurses. | Other | Intervention group (care with protocol) |
Primary outcome
Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU)
Time frame: Three weeks
With the application of CAM-ICU, an evaluation is made as "there is delirium" or "there is no delirium". CAM-ICU; It consists of four items including sudden change of consciousness or fluctuation in the patient's level of consciousness, attention assessment, and evaluation of thought organization and level of consciousness. According to this scale, in order for patients to be diagnosed with delirium, the first and second items and one of the third or fourth items must result in favor of delirium.
3 secondary outcomes
Glasgow Coma Scale (GCS)
Time frame: Three weeks
Richmond Agitation-Sedation Scale (RASS)
Time frame: Three weeks
Information Assessment Form for Postoperative Delirium (Pretest-Posttest)
Time frame: One week
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 20 Feb 2024.
- Background: PubMed 11445689Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
- Background: PubMed 12421743Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
- Background: PubMed 28187050Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
- Background: PubMed 22414419Allen SR, Frankel HL. Postoperative complications: delirium. Surg Clin North Am. 2012 Apr;92(2):409-31, x. doi: 10.1016/j.suc.2012.01.012.
- Background: PubMed 32222295Hshieh TT, Inouye SK, Oh ES. Delirium in the Elderly. Clin Geriatr Med. 2020 May;36(2):183-199. doi: 10.1016/j.cger.2019.11.001.
- Derived from this study: PubMed 39695628Soylemez GK, Bulut H. The effectiveness of postoperative delirium prevention, diagnosis, and intervention protocol in patients monitored in the intensive care unit after cardiac surgery: a quasi-experimental study. BMC Nurs. 2024 Dec 18;23(1):904. doi: 10.1186/s12912-024-02547-y.
- 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.
Gonul Kara Soylemez, MD principal investigator
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium. in people with Delirium, Postoperative, run by Gonul Kara Soylemez 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 8 inclusion and 4 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 20 Feb 2024. 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?
Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU) (time frame: Three weeks). 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 NCT06268119, which also lists 6 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 20 Feb 2024.