HypothermiaNCT02211703
National Epidemiologic Survey on the Incidence of Perioperative Hypothermia
An observational study of Hypothermia, run by Jie YI at 1 site in China.
Trial summary
Study Objective: to project the incidence of perioperative hypothermia in patients with elective surgery under general anesthesia in China to determine the risk factors associated with perioperative hypothermia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia
- How many people
- 2,208 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Dec 2015
- 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 with elective operation under general anesthesia
Who may be able to join
- Male or female，age≥18 Subjects will undergo an elective surgeries with general anaesthesia The duration of operation is expected to be over 60 minutes The subjects agreed to participate in the study and signed the consent form.
Who cannot join
- Central high fever, including that induced by cerebrovascular, disease, cerebral trauma, cerebral, surgeries, epilepsy and acute hydrocephalus Thermoregulation abnormalities including malignant hyperthermia (MHS) and neuroleptic malignant syndrome Hypothyroidism or hyperthyroidism diagnosed by substantial evidence Infectious fever Temperature is higher than 37.8℃ within 3 days before surgery Diseases or surgery that may lead to inaccuracy in measurement of era thermometer , such as ear infection etc.
- Surgeries with active cooling process during operation
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jie Yi, Doctoral, +86 10 69152025, easyue@163.com
About this study
Official title: National Epidemiologic Survey on the Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in China
Study Objective:
- to project the incidence of perioperative hypothermia in patients with elective surgery under general anesthesia in China
- to determine the risk factors associated with perioperative hypothermia.
- to explore the patient outcome of hypothermia such as cardiovascular events, wound infection,hospital stay and so on.
Study Design: The present study is a cross-sectional study with 30-day follow-up period.
Read the detailed description
This survey was anticipated to enroll 2208 patients with elective surgery under general anesthesia from 28 hospitals or so in China. After obtaining approval from the Ethical Committee related to research involving human subjects,the investigators will enroll the patients according to the inclusion and exclusion criterion. The tympanic temperature will be monitored at the following time points respectively: Arriving at waiting area, entering the OR room, 5 min before and after anesthesia induction, every 15 min during the operation, after 2h the tympanic temperature will be monitored at every 30 min, Tympanic temperature will also be taken when the surgery complete and when patients arrived at PACU. Other information will also be collected including the type and dosage of anesthesia drug,duration of surgery and anesthesia, patient warming method，operation room temperature, the amount of the infusion of intravenous fluids and blood and their warming techniques during the whole operation procedure. The postoperative follow-up will be conducted and recorded within 30 days after operation(for implantation surgery, the follow-up will be conducted within 90 days postoperatively ) which includes ICU stays, hospital stays, wound infection, new cardiovascular events.etc.
The contract research organization will be delegated to do an on site monitor once a month (online monitor once a week) for each hospital participate the survey during the recruitment and perform the source data validation at the same time to review the related medical records,source data and the case report forms, etc.to ensure the data accuracy and completeness.
Data management will be conducted through the whole survey procedure. In order to guarantee the validation of the data, two data managing staffs will input and verify the data independently.
Statistical analysis software (SAS9.2) was used for the calculation of all the statistical analyses. The number of cases, mean, standard deviation, median value, maximal value and minimal value should be calculated for the descriptions of the qualitative parameters. Number of cases and percentages are used for the descriptions on the classification parameters.Two side test is used for all the statistical tests, P<0.05 indicates that the difference is statistically significant (unless indicated otherwise), and 95% confidence is used as the confidence interval.
- Conditions
- Hypothermia
- Keywords
- perioperative hypothermia, Epidemiology, Tympanic temperature
- Medical subject headings
- Hypothermia
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 |
|---|---|---|
| Observation | This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of perioperative hypothermia
The core temperatures (tympanic membrane) will be measured at various time points to identify the occurence of hypothermia
Measured: from patients entered operating room to transfering to post anesthesia care units
Secondary outcomes (1)
record the postoperative adverse events
To identify the hypothermia related adverse events, such as cardiovascular events, wound infection, hospital stays and so on.
Measured: From the day after operation to 30 days thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie YI
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Consulting Center
- Responsible party
- Sponsor-investigator, Jie YI, Peking Union Medical College Hospital
- Investigators
- Yuguang Huang, doctoral, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211703
- Sponsor's protocol ID
- MDI0091
- Status last verified
- Aug 2014
- First submitted
- 6 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Epidemiologic Survey on the Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in China
- ClinicalTrials.gov ID
- NCT02211703
- Acronym / sponsor ID
- MDI0091
- Conditions
- Hypothermia
- Keywords
- perioperative hypothermia, Epidemiology, Tympanic temperature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,208 participants (estimated)
- Lead sponsor
- Jie YIUniversity, hospital or other
- Collaborators
- Medical Consulting Center
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Aug 2014 (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.
Study Objective:
- to project the incidence of perioperative hypothermia in patients with elective surgery under general anesthesia in China
- to determine the risk factors associated with perioperative hypothermia.
- to explore the patient outcome of hypothermia such as cardiovascular events, wound infection,hospital stay and so on.
Study Design: The present study is a cross-sectional study with 30-day follow-up period.
Detailed description
This survey was anticipated to enroll 2208 patients with elective surgery under general anesthesia from 28 hospitals or so in China. After obtaining approval from the Ethical Committee related to research involving human subjects,the investigators will enroll the patients according to the inclusion and exclusion criterion. The tympanic temperature will be monitored at the following time points respectively: Arriving at waiting area, entering the OR room, 5 min before and after anesthesia induction, every 15 min during the operation, after 2h the tympanic temperature will be monitored at every 30 min, Tympanic temperature will also be taken when the surgery complete and when patients arrived at PACU. Other information will also be collected including the type and dosage of anesthesia drug,duration of surgery and anesthesia, patient warming method，operation room temperature, the amount of the infusion of intravenous fluids and blood and their warming techniques during the whole operation procedure. The postoperative follow-up will be conducted and recorded within 30 days after operation(for implantation surgery, the follow-up will be conducted within 90 days postoperatively ) which includes ICU stays, hospital stays, wound infection, new cardiovascular events.etc.
The contract research organization will be delegated to do an on site monitor once a month (online monitor once a week) for each hospital participate the survey during the recruitment and perform the source data validation at the same time to review the related medical records,source data and the case report forms, etc.to ensure the data accuracy and completeness.
Data management will be conducted through the whole survey procedure. In order to guarantee the validation of the data, two data managing staffs will input and verify the data independently.
Statistical analysis software (SAS9.2) was used for the calculation of all the statistical analyses. The number of cases, mean, standard deviation, median value, maximal value and minimal value should be calculated for the descriptions of the qualitative parameters. Number of cases and percentages are used for the descriptions on the classification parameters.Two side test is used for all the statistical tests, P<0.05 indicates that the difference is statistically significant (unless indicated otherwise), and 95% confidence is used as the confidence interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with elective operation under general anesthesia
Key inclusion criteria (1 listed)
- Male or female，age≥18 Subjects will undergo an elective surgeries with general anaesthesia The duration of operation is expected to be over 60 minutes The subjects agreed to participate in the study and signed the consent form.
Key exclusion criteria (2 listed)
- Central high fever, including that induced by cerebrovascular, disease, cerebral trauma, cerebral, surgeries, epilepsy and acute hydrocephalus Thermoregulation abnormalities including malignant hyperthermia (MHS) and neuroleptic malignant syndrome Hypothyroidism or hyperthyroidism diagnosed by substantial evidence Infectious fever Temperature is higher than 37.8℃ within 3 days before surgery Diseases or surgery that may lead to inaccuracy in measurement of era thermometer , such as ear infection etc.
- Surgeries with active cooling process during 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
the incidence of perioperative hypothermia
Time frame: from patients entered operating room to transfering to post anesthesia care units
The core temperatures (tympanic membrane) will be measured at various time points to identify the occurence of hypothermia
1 secondary outcome
record the postoperative adverse events
Time frame: From the day after operation to 30 days thereafter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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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.
Yuguang Huang, doctoral principal investigator
Peking Union Medical College Hospital
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 Hypothermia, run by Jie YI 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 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: status not confirmed, as of the sponsor's last update on 7 Aug 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of perioperative hypothermia (time frame: from patients entered operating room to transfering to post anesthesia care units). 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 7 Aug 2014.