DeliriumNCT00991913
Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery
An observational study of Delirium, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Despite recent advances in postoperative delirium research, the proportion of patients with postoperative delirium is still high ranging between 20-80%. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2010to 30 Jun 2010
- 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: Patients over the age of 18yr, who were admitted to the PACU after elective surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)
Who may be able to join
- elective non-cardiovascular surgery
- general anesthesia
Who cannot join
- under 18yr of age
- under regional anaesthesia
- refused to sign consent form
- history of substance dependence
- underwent neurosurgery
- history of primary neurologic diseases
- stayed less than 10min in PACU
- received general anaesthesia but recovered in locations outside the recovery room
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery in Post-anaesthesia Care Unit
Despite recent advances in postoperative delirium research, the proportion of patients with postoperative delirium is still high ranging between 20-80%. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among patients undergoing non cardiovascular surgery.
Read the detailed description
Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to CAM-ICU criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.
- Conditions
- Delirium
- Keywords
- Delirium, Postoperative, Non-cardiovascular surgery, Post-anaesthesia care unit
- Medical subject headings
- Delirium
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 | Delirium was determined by CAM-ICU | |
| no Delirium | no Delirium was determined by CAM-ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of delirium in post anesthesia care unit (PACU) determined by confusion assessment method (CAM) -ICU criteria
Measured: at 1 hour after operation
Secondary outcomes (4)
heart rate in PACU
heart rate was recorded every 10 min during PACU stay, maximal and minimal heart rate were collected for analysis
Measured: every 10 mins
Pulse Oximeter Oxygen Saturation (SpO2) in PACU
Measured: every 10 mins
Hospital-length of stay
Measured: up to 6 months
Total health care fees
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study start1 Jun 2010
- Primary completion30 Jun 2010
- Study completion30 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Yuke Tian, MD., Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991913
- Sponsor's protocol ID
- TJHMZK02001
- Status last verified
- Jul 2020
- First submitted
- 7 Oct 2009
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery in Post-anaesthesia Care Unit
- ClinicalTrials.gov ID
- NCT00991913
- Acronym / sponsor ID
- TJHMZK02001
- Conditions
- Delirium
- Keywords
- Delirium, Postoperative, Non-cardiovascular surgery, Post-anaesthesia care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2010
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 8 Oct 2009 (estimated)
- 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.
Despite recent advances in postoperative delirium research, the proportion of patients with postoperative delirium is still high ranging between 20-80%. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among patients undergoing non cardiovascular surgery.
Detailed description
Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to CAM-ICU criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium | – | –Delirium was determined by CAM-ICU |
| no Delirium | – | –no Delirium was determined by CAM-ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18yr, who were admitted to the PACU after elective surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)
Key inclusion criteria (2 listed)
- elective non-cardiovascular surgery
- general anesthesia
Key exclusion criteria (8 listed)
- under 18yr of age
- under regional anaesthesia
- refused to sign consent form
- history of substance dependence
- underwent neurosurgery
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
The incidence of delirium in post anesthesia care unit (PACU) determined by confusion assessment method (CAM) -ICU criteria
Time frame: at 1 hour after operation
4 secondary outcomes
heart rate in PACU
Time frame: every 10 mins
Pulse Oximeter Oxygen Saturation (SpO2) in PACU
Time frame: every 10 mins
Hospital-length of stay
Time frame: up to 6 months
Total health care fees
Time frame: up to 6 months
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 21 Jul 2020.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Yuke Tian, MD. study chair
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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 Delirium, run by Huazhong University of Science and Technology 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 2 inclusion and 8 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 21 Jul 2020. 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?
The incidence of delirium in post anesthesia care unit (PACU) determined by confusion assessment method (CAM) -ICU criteria (time frame: at 1 hour after operation). 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 21 Jul 2020.