Sedation and AnalgesiaNCT07132450
Sedation and Analgesia Bundled Strategies Among ICU Nurses
An observational study of Sedation and Analgesia and Delirium, run by Ruijin Hospital.
Trial summary
This is a prospective observational study to investigate the current clinical practice status of sedation and analgesia bundled strategies among ICU nurses Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation and Analgesia, Delirium, Family Invlovement/Empowerment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 1 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: ICU nurses work from 28 provinces and cities in China
Who may be able to join
- possessing a valid nurse professional qualification certificate,
- having worked in an ICU for a minimum of one year.
Who cannot join
- nurses who were not working in the ICU during the study period
- those in rotation or undergoing advanced training. All subjects must sign the online informed consent form before filling out the questionnaire.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Current Practice of Sedation and Analgesia Bundled Strategies Among ICU Nurses: A National Cross-sectional Survey
This is a prospective observational study to investigate the current clinical practice status of sedation and analgesia bundled strategies among ICU nurses
Read the detailed description
Since the development of critical care medicine, analgesia and sedation management strategies have occupied an increasingly crucial position in the treatment of critically ill patients. Previous studies indicate that the traditional notion that deep sedation allows patients to "rest" and avoid painful memories is misguided. Deep sedation not only fails to deliver the anticipated benefits but is highly likely to prolong the patient's recovery cycle and impede physical recuperation.In actual intensive care practice, precisely and meticulously controlling the depth of analgesia and sedation is fundamental to ensuring patient comfort and the safety of clinical procedures. If the patient is in a state of pain and agitation, it is highly probable to trigger a series of severe adverse consequences, such as chronic pain and post-traumatic stress symptoms. These symptoms may persist long after the patient is discharged from the ICU, causing sustained damage to their physical and mental health. Simultaneously, the pain response significantly increases the patient's oxygen demand and the release of endogenous catecholamines, subsequently leading to a hypermetabolic state. These physiological changes will undoubtedly markedly delay the patient's recovery process.
Current critical care practices commonly emphasize the use of multimodal analgesia regimens, frequent assessment of patients' pain and sedation levels, and the implementation of light sedation using short-acting agents whenever feasible. These scientifically validated measures collectively form the influential ABCDEF bundled strategy (namely: Assessment, prevention, and management of pain; Both Spontaneous Awakening Trials (SATs) and Spontaneous Breathing Trials (SBTs); Choice of analgesia and sedation; Delirium assessment, prevention, and management; Early mobilization and Exercise; Family engagement and empowerment) .However, despite the significant theoretical advantages of the ABCDEF bundled strategy, its progress in actual clinical implementation has been slow. The sudden outbreak of the COVID-19 pandemic, in particular, delivered a substantial blow to healthcare systems. Compounded by multiple challenges such as drug shortages, resource constraints, and insufficient staffing, it has led to some irrational shifts in clinical practice. For instance, the proportion of deep sedation strategies has increased, the use frequency of benzodiazepines has risen, and compliance with daily sedation interruption has significantly decreased. These adverse changes severely compromise patient monitoring quality, subsequently exerting an extremely detrimental impact on patient prognosis.
Therefore, this study aims to gain insights into the current implementation status of the analgesia and sedation bundled strategy for critically ill patients among ICU nurses in China, as well as the underlying barriers. Its goal is to provide a robust and reliable scientific basis for optimizing the management strategies for critically ill patients and enhancing treatment outcomes.
- Medical subject headings
- Agnosia, Delirium, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU nurses | ICU nurses work form 28 provinces and cities in China. The inclusion criteria entailed: (1) possessing a valid nurse professional qualification certificate, and (2) having worked in an ICU for a minimum of one year. Conversely, the exclusion criteria stipulated: (1) nurses who were not working in the ICU during the study period, and (2) those in rotation or undergoing advanced training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of management of pain
A self-designed scale is used to evaluate the nurses clinical practice of the assessment, prevention and management of pain.The counting data is represented by frequency and percentiles. Items include:Use any scale to assess the patient's pain，Scale Commonly used for pain assessment，Administer analgesia to the patient in advance before nursing operations (such as venipuncture, exercise, etc.)，Work in accordance with the standardized procedures for pain management in the ICU.
Measured: Day 1
Scale of both spontaneous awakening tests(SATs) and spontaneous breathing tests(SBTs)
A self-designed scale is used to evaluate the nurses clinical practice of the SATs and SBTs experiment.The counting data is represented by frequency and percentiles. Project include:Frequency of the SATs conducted every day、Perform SBTs for mechanically ventilated patients every day、Work in accordance with the standardized procedures of "Awakening and Breathing" in the ICU、Role in SATs/SBTs.
Measured: Day 1
Scale of choice of sedation and analgesia
A self-designed scale is used to evaluate the clinical practice of nurses choice of sedation and analgesia. The counting data is represented by frequency and percentiles.Projects include:Scales commonly used to evaluate the sedation status、Work in accordance with the standardized procedures for sedation management in the ICU、Maintain the minimum sedation limit for the patient or no sedation strategy、Advise intensivists to reduce the use of benzodiazepines.
Measured: Day 1
Scale of delirium: assessment, prevention and management
A self-designed scale is used to evaluate the clinical practice of nurses in the assessment, prevention, and management of patients' delirium. The counting data is represented by frequency and percentiles.Projects include：Monitor delirium for ICU patients regularly、Scales commomly used to assess delirium、Role in delirium assessment、Pay attention to the underlying causes of delirium in patients、Examinations often being paid attention to understand the causes of delirium in patients、Measures are often taken to prevent delirium、Provide earplugs to patients for use、Non-pharmacological interventions to promote patient sleep、Advise intensivists to use drugs to promote sleep、Work in accordance with the standardized procedures for delirium management in the ICU、Provide cognitive stimulation to ICU patients
Measured: Day 1
Scale of early mobility and exercise
A self-designed scale is used to evaluate the clinical practice of nurses in the e early mobility and exercise. The counting data is represented by frequency and percentiles.Projects include：Evaluate the patient's ICU-AW、Common assessment tools used for ICU-AW、Implement early activities for ICU patients、ICU activity scales used for goal-directed early activity (e.g., SOMS, PFIT, CPAx, FSS-ICU)、Types of exercises offered for ICU patients、AS a member of the ICU rehabilitation team.
Measured: Day 1
Scale of family involvement and empowerment
A self-designed scale is used to evaluate the clinical practice of nurses in the patients' family involvement and empowerment. The counting data is represented by frequency and percentiles.Projects include：Explain delirium to family members、Enhance the delirium knowledge of family members through brochures or educational materials、Involve family members in delirium management、Strategies commonly used for family participation and empowerment.
Measured: Day 1
Secondary outcomes (1)
Scale of barriers in the current practice of bundled strategies in ICU nurses
A self-designed scale is used to exploring the barriers in the current practice of bundled strategies in ICU nurses.The counting data is represented by frequency and percentiles.Projects include：Barriers related to patients and family members、Barriers related to clinical medical staff、Barriers related to the bundled strategies、Barriers related to ICU environment.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation and AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 228 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132450
- Sponsor's protocol ID
- ZWQ21886-2025-427
- Status last verified
- Nov 2024
- First submitted
- 4 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Practice of Sedation and Analgesia Bundled Strategies Among ICU Nurses: A National Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT07132450
- Acronym / sponsor ID
- ZWQ21886-2025-427
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 20 Aug 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 is a prospective observational study to investigate the current clinical practice status of sedation and analgesia bundled strategies among ICU nurses
Detailed description
Since the development of critical care medicine, analgesia and sedation management strategies have occupied an increasingly crucial position in the treatment of critically ill patients. Previous studies indicate that the traditional notion that deep sedation allows patients to "rest" and avoid painful memories is misguided. Deep sedation not only fails to deliver the anticipated benefits but is highly likely to prolong the patient's recovery cycle and impede physical recuperation.In actual intensive care practice, precisely and meticulously controlling the depth of analgesia and sedation is fundamental to ensuring patient comfort and the safety of clinical procedures. If the patient is in a state of pain and agitation, it is highly probable to trigger a series of severe adverse consequences, such as chronic pain and post-traumatic stress symptoms. These symptoms may persist long after the patient is discharged from the ICU, causing sustained damage to their physical and mental health. Simultaneously, the pain response significantly increases the patient's oxygen demand and the release of endogenous catecholamines, subsequently leading to a hypermetabolic state. These physiological changes will undoubtedly markedly delay the patient's recovery process.
Current critical care practices commonly emphasize the use of multimodal analgesia regimens, frequent assessment of patients' pain and sedation levels, and the implementation of light sedation using short-acting agents whenever feasible. These scientifically validated measures collectively form the influential ABCDEF bundled strategy (namely: Assessment, prevention, and management of pain; Both Spontaneous Awakening Trials (SATs) and Spontaneous Breathing Trials (SBTs); Choice of analgesia and sedation; Delirium assessment, prevention, and management; Early mobilization and Exercise; Family engagement and empowerment) .However, despite the significant theoretical advantages of the ABCDEF bundled strategy, its progress in actual clinical implementation has been slow. The sudden outbreak of the COVID-19 pandemic, in particular, delivered a substantial blow to healthcare systems. Compounded by multiple challenges such as drug shortages, resource constraints, and insufficient staffing, it has led to some irrational shifts in clinical practice. For instance, the proportion of deep sedation strategies has increased, the use frequency of benzodiazepines has risen, and compliance with daily sedation interruption has significantly decreased. These adverse changes severely compromise patient monitoring quality, subsequently exerting an extremely detrimental impact on patient prognosis.
Therefore, this study aims to gain insights into the current implementation status of the analgesia and sedation bundled strategy for critically ill patients among ICU nurses in China, as well as the underlying barriers. Its goal is to provide a robust and reliable scientific basis for optimizing the management strategies for critically ill patients and enhancing treatment outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU nurses | – | –ICU nurses work form 28 provinces and cities in China. The inclusion criteria entailed: (1) possessing a valid nurse professional qualification certificate, and (2) having worked in an ICU for a minimum of one year. Conversely, the exclusion criteria stipulated: (1) nurses who were not working in the ICU during the study period, and (2) those in rotation or undergoing advanced training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU nurses work from 28 provinces and cities in China
Key inclusion criteria (2 listed)
- possessing a valid nurse professional qualification certificate,
- having worked in an ICU for a minimum of one year.
Key exclusion criteria (2 listed)
- nurses who were not working in the ICU during the study period
- those in rotation or undergoing advanced training. All subjects must sign the online informed consent form before filling out the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scale of management of pain
Time frame: Day 1
A self-designed scale is used to evaluate the nurses clinical practice of the assessment, prevention and management of pain.The counting data is represented by frequency and percentiles. Items include:Use any scale to assess the patient's pain，Scale Commonly used for pain assessment，Administer analgesia to the patient in advance before nursing operations (such as venipuncture, exercise, etc.)，Work in accordance with the standardized procedures for pain management in the ICU.
Scale of both spontaneous awakening tests(SATs) and spontaneous breathing tests(SBTs)
Time frame: Day 1
A self-designed scale is used to evaluate the nurses clinical practice of the SATs and SBTs experiment.The counting data is represented by frequency and percentiles. Project include:Frequency of the SATs conducted every day、Perform SBTs for mechanically ventilated patients every day、Work in accordance with the standardized procedures of "Awakening and Breathing" in the ICU、Role in SATs/SBTs.
Scale of choice of sedation and analgesia
Time frame: Day 1
A self-designed scale is used to evaluate the clinical practice of nurses choice of sedation and analgesia. The counting data is represented by frequency and percentiles.Projects include:Scales commonly used to evaluate the sedation status、Work in accordance with the standardized procedures for sedation management in the ICU、Maintain the minimum sedation limit for the patient or no sedation strategy、Advise intensivists to reduce the use of benzodiazepines.
Scale of delirium: assessment, prevention and management
Time frame: Day 1
A self-designed scale is used to evaluate the clinical practice of nurses in the assessment, prevention, and management of patients' delirium. The counting data is represented by frequency and percentiles.Projects include：Monitor delirium for ICU patients regularly、Scales commomly used to assess delirium、Role in delirium assessment、Pay attention to the underlying causes of delirium in patients、Examinations often being paid attention to understand the causes of delirium in patients、Measures are often taken to prevent delirium、Provide earplugs to patients for use、Non-pharmacological interventions to promote patient sleep、Advise intensivists to use drugs to promote sleep、Work in accordance with the standardized procedures for delirium management in the ICU、Provide cognitive stimulation to ICU patients
Scale of early mobility and exercise
Time frame: Day 1
A self-designed scale is used to evaluate the clinical practice of nurses in the e early mobility and exercise. The counting data is represented by frequency and percentiles.Projects include：Evaluate the patient's ICU-AW、Common assessment tools used for ICU-AW、Implement early activities for ICU patients、ICU activity scales used for goal-directed early activity (e.g., SOMS, PFIT, CPAx, FSS-ICU)、Types of exercises offered for ICU patients、AS a member of the ICU rehabilitation team.
Scale of family involvement and empowerment
Time frame: Day 1
A self-designed scale is used to evaluate the clinical practice of nurses in the patients' family involvement and empowerment. The counting data is represented by frequency and percentiles.Projects include：Explain delirium to family members、Enhance the delirium knowledge of family members through brochures or educational materials、Involve family members in delirium management、Strategies commonly used for family participation and empowerment.
1 secondary outcome
Scale of barriers in the current practice of bundled strategies in ICU nurses
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation and Analgesia and Delirium, run by Ruijin Hospital.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact weiqing Zhang Ph.D, Ph.D (8618521525300, weiq.zh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale of management of pain (time frame: Day 1). The study lists 6 primary outcomes in all. 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 20 Aug 2025.