Intensive CareNCT03087838
Postoperative Delirium in Adult Patients After Elective Craniotomy Under General Anaesthesia
An observational study of Intensive Care and Surgical, run by Capital Medical University at 1 site in China.
Trial summary
Postoperative delirium may result in many adverse complications. At present little is known about postoperative delirium in patients after crniotomy because they may manifest similar symptoms to definitely delirium for some structural brain disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care, Surgical, Postoperative Care
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 2 Feb 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients After Elective Craniotomy Under General Anaesthesia
Who may be able to join
- Adult patients after elective craniotomy under general anaesthesia and admitted to the ICU directly after surgery.
Who cannot join
- Patients younger than 18 years
- Patients with emergency operation
- Patients with preoperative impairment of consciousness (GCS<8)
- Patients with a past medical history of delirium or schizophrenia(evaluated by the medical document)
- Patients withventriculoperitoneal shunt or endoscope operation
- Patients with inability to communicate in the preoperative period(including language barrier)
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Postoperative Delirium in Adult Patients After Elective Craniotomy Under General Anaesthesia: a Prospective Cohort Study
Postoperative delirium may result in many adverse complications. At present little is known about postoperative delirium in patients after crniotomy because they may manifest similar symptoms to definitely delirium for some structural brain disease. Objective of this study is to find out incidence and risk factors of postoperative delirium in patients after elective craniotomy and also the relationship of postoperative delirium with clinical outcome.
Read the detailed description
The study is a prospective single-center cohort study. Consecutive adult patients admitted to the ICU after elective craniotomy is enrolled. Richmond Agitation Sedation Scale (RASS) is used to assess level of consciousness of patients; if conditions met "RASS≥-3", the Confusion Assessment Method for the Intensive Care Unit will proceed to evaluate delirium signs in patients. Delirium is assessed every 12-hour shift within 3 days during the patient's ICU stay and ended when discharged from ICU or dead, time started at 9am and 9pm. On the third day after operation when most patients have been transferred to general ward, delirium was assessed only at 9am for follow-up studies. Patients is divided into two groups via assessment of CAM-ICU: delirium groups and non-delirium groups. Factors potentially related to postoperative delirium are collected and categorized as preoperative, intraoperative and postoperative in chronological order. Univariate analyses between delirium groups and non-delirium groups is performed. The stepwise backward logistic regression is carried out to identify the independent predictors of delirium. Patients will be followed up until hospital discharge, death or 90 days after the enrollment. Clinical outcome such as days on the mechanical ventilator, endotracheal extubation time, need for re-intubation and tracheotomy, unexpected reoperation within 72 h after surgery, length of stay in the ICU , hospital costs and mortality will be registered.
- Conditions
- Intensive Care, Surgical, Postoperative Care, Neurosurgery
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 |
|---|---|---|
| delirium group | CAM-ICU is positive within the first 24 hours after operation | |
| non-delirium group | CAM-ICU is negative within the first 24 hours after operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
CAM-ICU is positive
Measured: Within the first 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Mar 2017
- Primary completion1 Nov 2017
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087838
- Sponsor's protocol ID
- KY2017-018-02
- Status last verified
- Feb 2018
- First submitted
- 17 Mar 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang X, Zhang G, Wang Y, Huang H, Li H, Li M, Yang C, Li M, Chen H, Jing B, Lin S. Alteration of default mode network: association with executive dysfunction in frontal glioma patients. J Neurosurg. 2022 Oct 14;138(6):1512-1521. doi: 10.3171/2022.8.JNS22591. Print 2023 Jun 1.
PubMed 36242576Wang CM, Huang HW, Wang YM, He X, Sun XM, Zhou YM, Zhang GB, Gu HQ, Zhou JX. Incidence and risk factors of postoperative delirium in patients admitted to the ICU after elective intracranial surgery: A prospective cohort study. Eur J Anaesthesiol. 2020 Jan;37(1):14-24. doi: 10.1097/EJA.0000000000001074.
PubMed 31464712
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium in Adult Patients After Elective Craniotomy Under General Anaesthesia: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03087838
- Acronym / sponsor ID
- KY2017-018-02
- Conditions
- Intensive Care, Surgical, Postoperative Care, Neurosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 23 Mar 2017 (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.
Postoperative delirium may result in many adverse complications. At present little is known about postoperative delirium in patients after crniotomy because they may manifest similar symptoms to definitely delirium for some structural brain disease. Objective of this study is to find out incidence and risk factors of postoperative delirium in patients after elective craniotomy and also the relationship of postoperative delirium with clinical outcome.
Detailed description
The study is a prospective single-center cohort study. Consecutive adult patients admitted to the ICU after elective craniotomy is enrolled. Richmond Agitation Sedation Scale (RASS) is used to assess level of consciousness of patients; if conditions met "RASS≥-3", the Confusion Assessment Method for the Intensive Care Unit will proceed to evaluate delirium signs in patients. Delirium is assessed every 12-hour shift within 3 days during the patient's ICU stay and ended when discharged from ICU or dead, time started at 9am and 9pm. On the third day after operation when most patients have been transferred to general ward, delirium was assessed only at 9am for follow-up studies. Patients is divided into two groups via assessment of CAM-ICU: delirium groups and non-delirium groups. Factors potentially related to postoperative delirium are collected and categorized as preoperative, intraoperative and postoperative in chronological order. Univariate analyses between delirium groups and non-delirium groups is performed. The stepwise backward logistic regression is carried out to identify the independent predictors of delirium. Patients will be followed up until hospital discharge, death or 90 days after the enrollment. Clinical outcome such as days on the mechanical ventilator, endotracheal extubation time, need for re-intubation and tracheotomy, unexpected reoperation within 72 h after surgery, length of stay in the ICU , hospital costs and mortality will be registered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delirium group | – | –CAM-ICU is positive within the first 24 hours after operation |
| non-delirium group | – | –CAM-ICU is negative within the first 24 hours after operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients After Elective Craniotomy Under General Anaesthesia
Key inclusion criteria (1 listed)
- Adult patients after elective craniotomy under general anaesthesia and admitted to the ICU directly after surgery.
Key exclusion criteria (7 listed)
- Patients younger than 18 years
- Patients with emergency operation
- Patients with preoperative impairment of consciousness (GCS<8)
- Patients with a past medical history of delirium or schizophrenia(evaluated by the medical document)
- Patients withventriculoperitoneal shunt or endoscope operation
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
Postoperative delirium
Time frame: Within the first 24 hours after operation
CAM-ICU is positive
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 12 Feb 2018.
- Derived from this study: PubMed 36242576Zhang X, Zhang G, Wang Y, Huang H, Li H, Li M, Yang C, Li M, Chen H, Jing B, Lin S. Alteration of default mode network: association with executive dysfunction in frontal glioma patients. J Neurosurg. 2022 Oct 14;138(6):1512-1521. doi: 10.3171/2022.8.JNS22591. Print 2023 Jun 1.
- Derived from this study: PubMed 31464712Wang CM, Huang HW, Wang YM, He X, Sun XM, Zhou YM, Zhang GB, Gu HQ, Zhou JX. Incidence and risk factors of postoperative delirium in patients admitted to the ICU after elective intracranial surgery: A prospective cohort study. Eur J Anaesthesiol. 2020 Jan;37(1):14-24. doi: 10.1097/EJA.0000000000001074.
- 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.
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?
An observational study of Intensive Care and Surgical, run by Capital Medical University 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 1 inclusion and 7 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 12 Feb 2018. 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?
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?
Postoperative delirium (time frame: Within the first 24 hours after operation). 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 NCT03087838, which also lists 2 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 12 Feb 2018.