Emergence DeliriumPODNCT06406257
Temperature Management on Postoperative Delirium
A study testing 3M™ Bair Hugger™ Warming Unit in people with Emergence Delirium, run by Wang Hongjian.
Trial summary
Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- 3M™ Bair Hugger™ Warming Unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 1 May 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Classified as American Society of Anesthesiologists I-III
- Hip surgery patients who agreed to the study
Who cannot join
- Non-consent to participate
- Diagnosed neurological or psychiatric disorders including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
- Coma, dementia, or language impairment affecting communication and assessment
- History of neurosurgery
- Use of antipsychotic medication preoperatively
- Body temperature exceeding 38°C within 24 hours before surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intraoperative Temperature Management on Postoperative Delirium in Elderly Patients Undergoing Hip Surgery
Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.
Read the detailed description
At present, the pathophysiological mechanisms contributing to postoperative delirium in elderly hip fracture patients remain elusive, with predominant research concentrating on neural inflammation, neurotransmitter dysregulation, and metabolic irregularities. The influence of perioperative temperature management on postoperative delirium remains uncertain and may correlate with surgical modality and intraoperative temperature modulation. Hence, this study endeavors to juxtapose intraoperative temperature variations among elderly hip fracture patients, probing their ramifications on postoperative delirium.
- Conditions
- Emergence Delirium
- Being tested
- 3M™ Bair Hugger™ Warming Unit
- Keywords
- Postoperative Delirium, Body Temperature, Hyperthermia, Hypothermia
- Medical subject headings
- Emergence Delirium, Hyperthermia, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ Bair Hugger™ Warming UnitDevice
Utilizing the 3M Temperature Management Unit to ensure intraoperative body temperature of elderly hip surgery patients remains consistent with their preoperative baseline, while patients in Group C receive no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Group C | No intervention | Patients in Group C will be covered with a bedsheet intraoperatively without active warming methods employed. |
| Group W | Experimental | Patients in Group W will have a 37°C forced-air warming blanket initiated upon entering the operating room to maintain their body temperature between 36-37 degrees Celsius. Receives: Device: 3M™ Bair Hugger™ Warming Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Confusion Assessment Method (CAM) was recorded before surgery, 10 min after admission to PACU, before exiting the post-anesthesia care unit (PACU), and 1, 2, and 3 days after surgery. POD was diagnosed if the patient had at least one episode of delirium at these time points after surgery.
The CAM diagnostic algorithm is based on four cardinal features of delirium: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium according to the CAM requires the presence of features 1, 2, and either 3 or 4.
Measured: Within 3 days after surgery
Secondary outcomes (2)
Incidence of intraoperative hypothermia
Perioperative hypothermia was defined as a drop in core temperature below 36 ℃. Intraoperative tympanic membrane temperature was measured to record the incidence and duration of hypothermia.
Measured: During operation
Pleiotropic cytokine in the patient's serum
Clinical trials and meta-analyses have identified the association between POD and increased perioperative levels of Interleukin-6 (IL-6), a pleiotropic cytokine that is both necessary and sufficient for postoperative memory decline in a preclinical model of POD.
Measured: Serum interleukin-6 (IL-6) levels before surgery and at 1, 2, and 3 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start20 May 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled participants were randomly assigned to a control group (Group C) or a body temperature protection group (Group W) in a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Hongjian
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Anhui Medical University
- Responsible party
- Sponsor-investigator, Wang Hongjian, Second People's Hospital of Hefei City
- Investigators
- Xianwen Hu, PhD, Study chair, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406257
- Sponsor's protocol ID
- 2024-keyan-045
- Acronym
- POD
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, it remains unclear how IPD sharing will be conducted.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Temperature Management on Postoperative Delirium in Elderly Patients Undergoing Hip Surgery
- ClinicalTrials.gov ID
- NCT06406257
- Acronym / sponsor ID
- POD / 2024-keyan-045
- Conditions
- Emergence Delirium
- Keywords
- Postoperative Delirium, Body Temperature, Hyperthermia, Hypothermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wang HongjianUniversity, hospital or other
- Collaborators
- The Second Hospital of Anhui Medical University
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 9 May 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.
Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.
Detailed description
At present, the pathophysiological mechanisms contributing to postoperative delirium in elderly hip fracture patients remain elusive, with predominant research concentrating on neural inflammation, neurotransmitter dysregulation, and metabolic irregularities. The influence of perioperative temperature management on postoperative delirium remains uncertain and may correlate with surgical modality and intraoperative temperature modulation. Hence, this study endeavors to juxtapose intraoperative temperature variations among elderly hip fracture patients, probing their ramifications on postoperative delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled participants were randomly assigned to a control group (Group C) or a body temperature protection group (Group W) in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –Patients in Group C will be covered with a bedsheet intraoperatively without active warming methods employed. |
| Group W | Experimental | Device: 3M™ Bair Hugger™ Warming UnitPatients in Group W will have a 37°C forced-air warming blanket initiated upon entering the operating room to maintain their body temperature between 36-37 degrees Celsius. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years
- Classified as American Society of Anesthesiologists I-III
- Hip surgery patients who agreed to the study
Key exclusion criteria (6 listed)
- Non-consent to participate
- Diagnosed neurological or psychiatric disorders including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
- Coma, dementia, or language impairment affecting communication and assessment
- History of neurosurgery
- Use of antipsychotic medication preoperatively
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 |
|---|---|---|
| 3M™ Bair Hugger™ Warming UnitUtilizing the 3M Temperature Management Unit to ensure intraoperative body temperature of elderly hip surgery patients remains consistent with their preoperative baseline, while patients in Group C receive no intervention. | Device | Group W |
Primary outcome
Incidence of postoperative delirium
Time frame: Within 3 days after surgery
Confusion Assessment Method (CAM) was recorded before surgery, 10 min after admission to PACU, before exiting the post-anesthesia care unit (PACU), and 1, 2, and 3 days after surgery. POD was diagnosed if the patient had at least one episode of delirium at these time points after surgery. The CAM diagnostic algorithm is based on four cardinal features of delirium: 1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking, and 4) altered level of consciousness. A diagnosis of delirium according to the CAM requires the presence of features 1, 2, and either 3 or 4.
2 secondary outcomes
Incidence of intraoperative hypothermia
Time frame: During operation
Pleiotropic cytokine in the patient's serum
Time frame: Serum interleukin-6 (IL-6) levels before surgery and at 1, 2, and 3 days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No. Currently, it remains unclear how IPD sharing will be conducted.
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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.
Xianwen Hu, PhD study chair
The Second Hospital of Anhui Medical University
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ Bair Hugger™ Warming Unit in people with Emergence Delirium, run by Wang Hongjian.
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 3 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: status not confirmed, as of the sponsor's last update on 14 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongjian Wang, MD (+86 15806019263, wanghj_a@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: Within 3 days after surgery). 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 14 May 2024.