Delirium in the Intensive Care UnitNCT07054268
Nurse-Led Implementation of the ABCDEF Bundle
A study testing Nurse-Led ABCDEF Bundle Implementation in people with Delirium in the Intensive Care Unit, run by Helwan University at 1 site in Egypt.
Trial summary
This study evaluated the effectiveness of a nurse-led implementation of the ABCDEF bundle, an evidence-based, interprofessional care framework, in the prevention and management of delirium among Intensive Care Unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Delirium in the Intensive Care Unit
- What is being tested?
- Nurse-Led ABCDEF Bundle Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Sep 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Critically ill adult patients aged 18 years or older
- Admitted to the ICU at Ain Shams University Hospitals within 48 hours of enrollment
- Clinically stable to undergo assessment and nursing intervention
- Able to provide informed consent personally or via a legally authorized representative
- Both male and female patients included
Who cannot join
- Documented cognitive impairment or pre-existing psychiatric illness
- Severe neurological conditions (e.g., advanced stroke, traumatic brain injury)
- Deep sedation level (Richmond Agitation-Sedation Scale [RASS] score < -4)
- Terminal illness requiring palliative or end-of-life care
- Patients who declined participation or did not meet eligibility screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-Led Implementation of the ABCDEF Bundle: Evidence-Based Strategies for ICU Delirium Management
This study evaluated the effectiveness of a nurse-led implementation of the ABCDEF bundle, an evidence-based, interprofessional care framework, in the prevention and management of delirium among Intensive Care Unit (ICU) patients. The intervention aimed to reduce the incidence and severity of ICU delirium, decrease agitation, and improve patient outcomes through structured nursing interventions guided by the ABCDEF approach.
Read the detailed description
The study employed a single-center, quasi-experimental clinical design with two parallel groups: an intervention group that received the nurse-led ABCDEF bundle and a control group that received standard ICU care. No randomization was applied, but baseline characteristics were matched where possible to control for confounding variables.
The study was conducted in the adult ICU of a tertiary care hospital. Eligible participants included adult patients (≥18 years) who were admitted to the ICU with an expected stay of at least 48 hours. Patients with pre-existing cognitive impairment, severe neurological damage, or those in a persistent vegetative state were excluded.
The intervention group received structured nursing care guided by the ABCDEF bundle, delivered by trained ICU nurses. The protocol included routine pain assessments and management strategies; daily spontaneous awakening and breathing trials; evidence-based sedation choices minimizing benzodiazepine use; systematic delirium screening using a validated tool (e.g., ICDSC); early mobilization practices appropriate to the patient's clinical status; and inclusion of family members in care planning and education.
The control group received usual ICU care without the formal implementation of the ABCDEF bundle.
The primary outcome was the incidence of delirium during the ICU stay, measured using a validated tool (e.g., ICDSC or CAM-ICU). Secondary outcomes included agitation levels, duration of delirium episodes, ICU length of stay, adherence to individual ABCDEF components, use of physical restraints, and sedative/analgesic dosages.
Data were collected prospectively from patient medical records, bedside observations, and standardized assessment tools. Daily monitoring was conducted to ensure fidelity to the intervention and accurate documentation of outcomes.
Ethical approval was obtained from the institutional review board. Written informed consent was obtained from patients or their legal representatives where applicable.
- Conditions
- Delirium in the Intensive Care Unit
- Being tested
- Nurse-Led ABCDEF Bundle Implementation
- Keywords
- ICU delirium, evidence-based nursing, nursing interventions, critical care, patient outcomes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led ABCDEF Bundle ImplementationOther
This intervention is distinguished by its structured, nurse-led delivery of all six components of the ABCDEF bundle, with nurses serving as primary implementers rather than multidisciplinary teams. Unlike other studies that may focus on select elements of the bundle or physician-led application, this study emphasizes standardized nursing protocols and daily documentation to ensure consistent implementation and evaluation across all components specifically targeting delirium prevention and management in ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The study group received a nurse-led implementation of the ABCDEF bundle, which included structured interventions to assess and manage pain, conduct spontaneous awakening and breathing trials, optimize sedation choices, screen for and manage delirium, promote early mobility, and engage family members. ICU nurses delivered the intervention following standardized protocols to ensure consistency and adherence to the bundle components. Receives: Other: Nurse-Led ABCDEF Bundle Implementation |
| control group | No intervention | The control group received standard ICU care as per the hospital's existing protocols. No structured implementation of the ABCDEF bundle was applied, and nursing care followed routine clinical practices without specific emphasis on coordinated bundle elements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ICU Delirium
The presence or absence of delirium will be assessed daily using the Intensive Care Delirium Screening Checklist (ICDSC), a validated tool. Delirium is defined as an ICDSC score ≥4. The outcome will measure the proportion of patients who develop delirium during their ICU stay.
Measured: From ICU admission to ICU discharge or up to 7 days, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in the Intensive Care UnitStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Eldin Moustafa Hamed, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054268
- Sponsor's protocol ID
- NURSERC2023/12/10
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Implementation of the ABCDEF Bundle: Evidence-Based Strategies for ICU Delirium Management
- ClinicalTrials.gov ID
- NCT07054268
- Acronym / sponsor ID
- NURSERC2023/12/10
- Conditions
- Delirium in the Intensive Care Unit
- Keywords
- ICU delirium, evidence-based nursing, nursing interventions, critical care, patient outcomes.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Jul 2025 (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 evaluated the effectiveness of a nurse-led implementation of the ABCDEF bundle, an evidence-based, interprofessional care framework, in the prevention and management of delirium among Intensive Care Unit (ICU) patients. The intervention aimed to reduce the incidence and severity of ICU delirium, decrease agitation, and improve patient outcomes through structured nursing interventions guided by the ABCDEF approach.
Detailed description
The study employed a single-center, quasi-experimental clinical design with two parallel groups: an intervention group that received the nurse-led ABCDEF bundle and a control group that received standard ICU care. No randomization was applied, but baseline characteristics were matched where possible to control for confounding variables.
The study was conducted in the adult ICU of a tertiary care hospital. Eligible participants included adult patients (≥18 years) who were admitted to the ICU with an expected stay of at least 48 hours. Patients with pre-existing cognitive impairment, severe neurological damage, or those in a persistent vegetative state were excluded.
The intervention group received structured nursing care guided by the ABCDEF bundle, delivered by trained ICU nurses. The protocol included routine pain assessments and management strategies; daily spontaneous awakening and breathing trials; evidence-based sedation choices minimizing benzodiazepine use; systematic delirium screening using a validated tool (e.g., ICDSC); early mobilization practices appropriate to the patient's clinical status; and inclusion of family members in care planning and education.
The control group received usual ICU care without the formal implementation of the ABCDEF bundle.
The primary outcome was the incidence of delirium during the ICU stay, measured using a validated tool (e.g., ICDSC or CAM-ICU). Secondary outcomes included agitation levels, duration of delirium episodes, ICU length of stay, adherence to individual ABCDEF components, use of physical restraints, and sedative/analgesic dosages.
Data were collected prospectively from patient medical records, bedside observations, and standardized assessment tools. Daily monitoring was conducted to ensure fidelity to the intervention and accurate documentation of outcomes.
Ethical approval was obtained from the institutional review board. Written informed consent was obtained from patients or their legal representatives where applicable.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Nurse-Led ABCDEF Bundle ImplementationThe study group received a nurse-led implementation of the ABCDEF bundle, which included structured interventions to assess and manage pain, conduct spontaneous awakening and breathing trials, optimize sedation choices, screen for and manage delirium, promote early mobility, and engage family members. ICU nurses delivered the intervention following standardized protocols to ensure consistency and adherence to the bundle components. |
| control group | No intervention | –The control group received standard ICU care as per the hospital's existing protocols. No structured implementation of the ABCDEF bundle was applied, and nursing care followed routine clinical practices without specific emphasis on coordinated bundle elements. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Critically ill adult patients aged 18 years or older
- Admitted to the ICU at Ain Shams University Hospitals within 48 hours of enrollment
- Clinically stable to undergo assessment and nursing intervention
- Able to provide informed consent personally or via a legally authorized representative
- Both male and female patients included
Key exclusion criteria (5 listed)
- Documented cognitive impairment or pre-existing psychiatric illness
- Severe neurological conditions (e.g., advanced stroke, traumatic brain injury)
- Deep sedation level (Richmond Agitation-Sedation Scale [RASS] score < -4)
- Terminal illness requiring palliative or end-of-life care
- Patients who declined participation or did not meet eligibility screening
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 |
|---|---|---|
| Nurse-Led ABCDEF Bundle ImplementationThis intervention is distinguished by its structured, nurse-led delivery of all six components of the ABCDEF bundle, with nurses serving as primary implementers rather than multidisciplinary teams. Unlike other studies that may focus on select elements of the bundle or physician-led application, this study emphasizes standardized nursing protocols and daily documentation to ensure consistent implementation and evaluation across all components specifically targeting delirium prevention and management in ICU patients. | Other | Study Group |
Primary outcome
Incidence of ICU Delirium
Time frame: From ICU admission to ICU discharge or up to 7 days, whichever occurs first
The presence or absence of delirium will be assessed daily using the Intensive Care Delirium Screening Checklist (ICDSC), a validated tool. Delirium is defined as an ICDSC score ≥4. The outcome will measure the proportion of patients who develop delirium during their ICU stay.
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 8 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Delirium in the Intensive Care Unit
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Recruiting
Neurosteer Bedside Monitoring System
Delirium, Sedation
Not yet recruitingPhase 3
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
Delirium in the Intensive Care Unit
Not yet recruiting
Sleep Harmonization Via Bundled Team-Based Interventions in the ICU
Sleep Deprivation, Critical Illness
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 Nurse-Led ABCDEF Bundle Implementation in people with Delirium in the Intensive Care Unit, run by Helwan University at 1 site in Egypt.
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 5 inclusion and 5 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 8 Jul 2025. 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 Egypt. 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?
Incidence of ICU Delirium (time frame: From ICU admission to ICU discharge or up to 7 days, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2025.