Hip OrthopaedicUPEDNCT07820007
Cohort Study of Perioperative Ultrasound and Delirium Following Hip Surgery
An observational study of Hip Orthopaedic, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
Trial summary
About this study This is a single-center prospective observational cohort study involving older adults undergoing hip surgery. The investigators will collect clinical and ultrasound-related information without changing routine treatment, anaesthesia, or surgical plans. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Orthopaedic
- What is being tested?
- Peri-operative observational data collection of bedside ultrasound and hemodynamic parameters
- How many people
- 620 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 10 Aug 2027
- How long will I take part?
- 5 Days
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This single-center prospective observational cohort study will enroll consecutive patients aged 65 years or older who are scheduled to receive hip orthopedic surgery. Most participants are older adults with hip fractures, such as femoral neck fracture or intertrochanteric fracture. Participants will receive routine clinical, anesthetic and surgical care without any study-related modification. Patients or their legal representatives must provide written informed consent prior to enrollment. Healthy volunteers will not be recruited. The total number of analyzable participants is planned to be 450, while approximately 620 candidates will be screened to account for possible drop-outs, missing ultrasound data or incomplete postoperative delirium assessments.
Who may be able to join
- Aged 65 years or older
- Scheduled for hip orthopedic surgery, including artificial femoral head replacement for femoral neck fracture, PFNA internal fixation for intertrochanteric fracture, total hip arthroplasty, and other hip-related operations
- Expected postoperative hospital stay of 3 days or longer
- Bedside carotid ultrasound and optic nerve sheath diameter (ONSD) measurement can be completed before anesthesia, or can be performed without interfering with clinical treatment as judged by investigators
- Written informed consent obtained from the patient or their legal representative
Who cannot join
- Pre-existing delirium or severe dementia before surgery, which prevents valid cognitive and postoperative delirium assessment
- Recent acute stroke, intracranial hemorrhage, or other acute neurological emergencies
- Severe ocular disease, ocular trauma, recent ophthalmic surgery, or other conditions unsuitable for ONSD measurement
- History of neck surgery, neck injury, dressing coverage, or poor acoustic window that prevents carotid ultrasound examination
- Immediate postoperative transfer to another hospital, continuous sedation, or endotracheal intubation leading to inability to assess postoperative delirium
- Refusal to participate in the study or withdrawal of informed consent at any stage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Hebei Province
Cangzhou, Hebei
Wudong Last Name：Zhuang, MD, 8618932789870, laozhuang1015@163.com
About this study
Official title: Single-Center Prospective Observational Cohort Study of Perioperative Point-of-Care Ultrasound and Hemodynamic Status on Postoperative Delirium and Clinical Outcomes in Elderly Patients With Hip Orthopedic Fractures
About this study
This is a single-center prospective observational cohort study involving older adults undergoing hip surgery. The investigators will collect clinical and ultrasound-related information without changing routine treatment, anaesthesia, or surgical plans. The purpose of this study is to determine whether certain bedside ultrasound measurements and blood-flow status around the time of surgery are associated with postoperative delirium and other patient outcomes.
Read more
What is the aim of this study?
Postoperative delirium is a state of sudden confusion that may occur after surgery in older patients. This study focuses on older patients undergoing hip orthopaedic surgery. The investigators aim to explore the relationships between peri-operative bedside ultrasound findings, hemodynamic (blood flow and circulation) status, and the occurrence of postoperative delirium.
The study will focus on several ultrasound measurements, including pre-operative carotid artery plaque burden, corrected flow time of the common carotid artery (FTc), and optic nerve sheath diameter (ONSD). The investigators will assess the associations between these measurements and postoperative delirium, and will further analyse how these factors may influence postoperative prognosis and clinical outcomes.
What will happen in this study?
This is an observational study. No experimental drugs or treatments will be administered to participants. Standard hospital care will not be altered because of participation in this study. Participants aged 65 years or older who are scheduled for hip orthopaedic surgery will be continuously enrolled. Information will be collected in four parts:
Pre-operative assessment (before anaesthesia)
Bedside ultrasound scans will be performed. The investigators will assess carotid artery plaque burden, measure corrected flow time (FTc) of the common carotid artery, and measure optic nerve sheath diameter (ONSD). General background information and existing medical conditions of participants will also be recorded.
Intra-operative monitoring (during surgery)
The investigators will document circulation-related data, including blood pressure, heart rate, oxygen levels, type of anaesthesia, medicines administered, and surgical details, to evaluate changes in circulatory status during the operation.
Post-operative assessment (after surgery)
From postoperative day 1 to postoperative day 5, or until hospital discharge (whichever occurs first), staff members will assess participants daily for signs of postoperative delirium. Clinical outcome information will also be collected, including postoperative complications (such as pneumonia), pain scores, and length of hospital stay.
Data analysis
The investigators will analyse the collected data. The study will examine associations between peri-operative ultrasound and hemodynamic parameters and postoperative delirium. The investigators will evaluate whether these ultrasound measurements can help predict the risk of postoperative delirium and explore relationships between these measurements and postoperative clinical outcomes.
Why is this research being conducted?
By collecting objective peri-operative measurements, the investigators aim to clarify the relationships between these factors, postoperative delirium, and real-world clinical outcomes. Findings from this study may help clinicians better evaluate surgical risks for older adults undergoing hip surgery in the future.
- Conditions
- Hip Orthopaedic
- Being tested
- Peri-operative observational data collection of bedside ultrasound and hemodynamic parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-operative observational data collection of bedside ultrasound and hemodynamic parametersOther
No investigational therapeutic interventions are performed in this study. This is purely observational data collection. Pre-anesthesia bedside ultrasound measurements including carotid artery plaque burden, common carotid corrected flow time (FTc), and optic nerve sheath diameter (ONSD) are obtained for research purposes only. Intra-operative hemodynamic variables such as blood pressure, heart rate, hypotension and hypoxia events are recorded. Routine clinical care, anesthesia and surgical strategies of participants remain unchanged. No study-specific treatment is delivered.
| Study group | Role | What they receive |
|---|---|---|
| Overall Study Cohort | Single-center prospective observational cohort. Consecutive patients aged ≥65 years undergoing hip orthopedic surgery are enrolled. No standard clinical care, anesthesia or surgical management is modified for research. Peri-operative bedside ultrasound and hemodynamic data are collected for observational analysis. Analyzable sample size: 450 subjects. No control arm. Receives: Other: Peri-operative observational data collection of bedside ultrasound and hemodynamic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Postoperative delirium will be screened daily by trained research personnel using the Confusion Assessment Method (CAM). A positive CAM assessment at any time point defines postoperative delirium. This outcome will be used to assess associations between preoperative ultrasound parameters, peri-operative hemodynamic status and the risk of postoperative delirium.
Measured: Postoperative day 1 to postoperative day 5, or prior to hospital discharge (whichever occurs first)
Secondary outcomes (8)
Carotid artery plaque burden
Pre-anesthesia bilateral carotid bedside ultrasound is performed to evaluate atherosclerotic plaque burden. Its association with postoperative delirium risk will be analyzed.
Measured: Before anesthesia (pre-operative)
Corrected flow time of the common carotid artery (FTc)
Corrected flow time (FTc) of the common carotid artery is measured by pre-anesthesia bedside ultrasound to reflect circulatory volume and cardiovascular function, and analyzed for correlation with postoperative delirium and clinical outcomes.
Measured: Before anesthesia (pre-operative)
Mean optic nerve sheath diameter (ONSD)
Mean optic nerve sheath diameter is obtained via pre-anesthesia bedside ocular ultrasound as an indirect marker of intracranial status, to explore its relationship with postoperative delirium.
Measured: Before anesthesia (pre-operative)
Intraoperative hypotension episodes
Intraoperative hypotension events are identified based on mean arterial pressure (MAP) recordings during anesthesia and surgery. Associations between hemodynamic fluctuations and postoperative delirium as well as clinical outcomes will be explored.
Measured: During surgery and anesthesia
Intraoperative hypoxia episodes
Intraoperative hypoxia events are determined from continuous pulse oximetry (SpO₂) records to evaluate peri-operative oxygenation and its links with postoperative adverse events.
Measured: During surgery and anesthesia
Maximum postoperative pain score within 24 hours
The highest pain score within 24 hours after surgery is assessed using the Numeric Rating Scale (NRS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain severity and a worse outcome. The relationship between postoperative pain burden and delirium and clinical outcomes will be analyzed.
Measured: Within 24 hours after surgery
Incidence of postoperative pneumonia
Postoperative pneumonia is diagnosed according to clinical symptoms, imaging results, and medical records as a measure of postoperative complication. The incidence of postoperative pneumonia will be assessed during the postoperative period.
Measured: Perioperative/Periprocedural"
Postoperative length of hospital stay
Duration of hospital stay after surgery will be extracted from medical records to evaluate postoperative recovery and overall clinical outcomes.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OrthopaedicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 620 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820007
- Sponsor's protocol ID
- CZX2026-KY066-02
- Acronym
- UPED
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Prospective Observational Cohort Study of Perioperative Point-of-Care Ultrasound and Hemodynamic Status on Postoperative Delirium and Clinical Outcomes in Elderly Patients With Hip Orthopedic Fractures
- ClinicalTrials.gov ID
- NCT07820007
- Acronym / sponsor ID
- UPED / CZX2026-KY066-02
- Conditions
- Hip Orthopaedic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 15 Sep 2026 (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.
About this study
This is a single-center prospective observational cohort study involving older adults undergoing hip surgery. The investigators will collect clinical and ultrasound-related information without changing routine treatment, anaesthesia, or surgical plans. The purpose of this study is to determine whether certain bedside ultrasound measurements and blood-flow status around the time of surgery are associated with postoperative delirium and other patient outcomes.
What is the aim of this study?
Postoperative delirium is a state of sudden confusion that may occur after surgery in older patients. This study focuses on older patients undergoing hip orthopaedic surgery. The investigators aim to explore the relationships between peri-operative bedside ultrasound findings, hemodynamic (blood flow and circulation) status, and the occurrence of postoperative delirium.
The study will focus on several ultrasound measurements, including pre-operative carotid artery plaque burden, corrected flow time of the common carotid artery (FTc), and optic nerve sheath diameter (ONSD). The investigators will assess the associations between these measurements and postoperative delirium, and will further analyse how these factors may influence postoperative prognosis and clinical outcomes.
What will happen in this study?
This is an observational study. No experimental drugs or treatments will be administered to participants. Standard hospital care will not be altered because of participation in this study. Participants aged 65 years or older who are scheduled for hip orthopaedic surgery will be continuously enrolled. Information will be collected in four parts:
Pre-operative assessment (before anaesthesia)
Bedside ultrasound scans will be performed. The investigators will assess carotid artery plaque burden, measure corrected flow time (FTc) of the common carotid artery, and measure optic nerve sheath diameter (ONSD). General background information and existing medical conditions of participants will also be recorded.
Intra-operative monitoring (during surgery)
The investigators will document circulation-related data, including blood pressure, heart rate, oxygen levels, type of anaesthesia, medicines administered, and surgical details, to evaluate changes in circulatory status during the operation.
Post-operative assessment (after surgery)
From postoperative day 1 to postoperative day 5, or until hospital discharge (whichever occurs first), staff members will assess participants daily for signs of postoperative delirium. Clinical outcome information will also be collected, including postoperative complications (such as pneumonia), pain scores, and length of hospital stay.
Data analysis
The investigators will analyse the collected data. The study will examine associations between peri-operative ultrasound and hemodynamic parameters and postoperative delirium. The investigators will evaluate whether these ultrasound measurements can help predict the risk of postoperative delirium and explore relationships between these measurements and postoperative clinical outcomes.
Why is this research being conducted?
By collecting objective peri-operative measurements, the investigators aim to clarify the relationships between these factors, postoperative delirium, and real-world clinical outcomes. Findings from this study may help clinicians better evaluate surgical risks for older adults undergoing hip surgery in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Study Cohort | – | Other: Peri-operative observational data collection of bedside ultrasound and hemodynamic parametersSingle-center prospective observational cohort. Consecutive patients aged ≥65 years undergoing hip orthopedic surgery are enrolled. No standard clinical care, anesthesia or surgical management is modified for research. Peri-operative bedside ultrasound and hemodynamic data are collected for observational analysis. Analyzable sample size: 450 subjects. No control arm. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This single-center prospective observational cohort study will enroll consecutive patients aged 65 years or older who are scheduled to receive hip orthopedic surgery. Most participants are older adults with hip fractures, such as femoral neck fracture or intertrochanteric fracture. Participants will receive routine clinical, anesthetic and surgical care without any study-related modification. Patients or their legal representatives must provide written informed consent prior to enrollment. Healthy volunteers will not be recruited. The total number of analyzable participants is planned to be 450, while approximately 620 candidates will be screened to account for possible drop-outs, missing ultrasound data or incomplete postoperative delirium assessments.
Key inclusion criteria (5 listed)
- Aged 65 years or older
- Scheduled for hip orthopedic surgery, including artificial femoral head replacement for femoral neck fracture, PFNA internal fixation for intertrochanteric fracture, total hip arthroplasty, and other hip-related operations
- Expected postoperative hospital stay of 3 days or longer
- Bedside carotid ultrasound and optic nerve sheath diameter (ONSD) measurement can be completed before anesthesia, or can be performed without interfering with clinical treatment as judged by investigators
- Written informed consent obtained from the patient or their legal representative
Key exclusion criteria (6 listed)
- Pre-existing delirium or severe dementia before surgery, which prevents valid cognitive and postoperative delirium assessment
- Recent acute stroke, intracranial hemorrhage, or other acute neurological emergencies
- Severe ocular disease, ocular trauma, recent ophthalmic surgery, or other conditions unsuitable for ONSD measurement
- History of neck surgery, neck injury, dressing coverage, or poor acoustic window that prevents carotid ultrasound examination
- Immediate postoperative transfer to another hospital, continuous sedation, or endotracheal intubation leading to inability to assess postoperative delirium
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 |
|---|---|---|
| Peri-operative observational data collection of bedside ultrasound and hemodynamic parametersNo investigational therapeutic interventions are performed in this study. This is purely observational data collection. Pre-anesthesia bedside ultrasound measurements including carotid artery plaque burden, common carotid corrected flow time (FTc), and optic nerve sheath diameter (ONSD) are obtained for research purposes only. Intra-operative hemodynamic variables such as blood pressure, heart rate, hypotension and hypoxia events are recorded. Routine clinical care, anesthesia and surgical strategies of participants remain unchanged. No study-specific treatment is delivered. | Other | Overall Study Cohort |
Primary outcome
Incidence of postoperative delirium
Time frame: Postoperative day 1 to postoperative day 5, or prior to hospital discharge (whichever occurs first)
Postoperative delirium will be screened daily by trained research personnel using the Confusion Assessment Method (CAM). A positive CAM assessment at any time point defines postoperative delirium. This outcome will be used to assess associations between preoperative ultrasound parameters, peri-operative hemodynamic status and the risk of postoperative delirium.
8 secondary outcomes
Carotid artery plaque burden
Time frame: Before anesthesia (pre-operative)
Corrected flow time of the common carotid artery (FTc)
Time frame: Before anesthesia (pre-operative)
Mean optic nerve sheath diameter (ONSD)
Time frame: Before anesthesia (pre-operative)
Intraoperative hypotension episodes
Time frame: During surgery and anesthesia
Intraoperative hypoxia episodes
Time frame: During surgery and anesthesia
Maximum postoperative pain score within 24 hours
Time frame: Within 24 hours after surgery
Incidence of postoperative pneumonia
Time frame: Perioperative/Periprocedural"
Postoperative length of hospital stay
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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 15 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Orthopaedic, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
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 6 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 15 Sep 2026. 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 China. 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?
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 Wudong Last Name：Zhuang, MD (8618932789870, laozhuang1015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Postoperative day 1 to postoperative day 5, or prior to hospital discharge (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 15 Sep 2026.