Disturbance; Temperature RegulationNCT03081000
Perioperative Hypothermia: A Multi-center Study of Incidence, Risk Factors and Preventive Measures.
An observational study of Disturbance; Temperature Regulation, run by KK Women's and Children's Hospital at 5 sites in Singapore.
Trial summary
Aims:- Primary: To identify the incidence of intra-operative and post-operative hypothermia Secondary: To identify factors contributing to peri-operative hypothermia. To identify current anaesthetic practice in peri-operative temperature monitoring, use of active/warming measures by anaesthetists in various hospitals. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Disturbance; Temperature Regulation
- How many people
- 4,000 participants
- Where
- 5 sitesSingapore
- Study dates
- Oct 2015to Jun 2017
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a prospective cross-sectional observational study, aiming to recruit 4000 patients of all ages, going for surgery (day surgery/inpatient, elective/emergency). , not involving the use of extra-corporeal circuits, across 5 institutions (KKWCH, CGH, SGH, TTSH, KTPH) over the course of 6 months (oct 2015 to Mar 2016).Recruitment will be done over 1-2 months period at each site by 3 co-Investigators as they rotate through each of the anaesthetic department as part of their residency postings. A consultant site-Principal Investigator will be in charge of supervising the co-Investigators during the recruitment at each site.
Who may be able to join
- All cases within specified time frame under General anaesthesia (GA), Regional anaesthesia (RA), or combined General and Regional Anaesthesia (GA/RA) not involving the use of extra-corporeal circuits.
Who cannot join
- Cases done under Monitored Anaesthesia Care (MAC) or that have the use of extracorporeal circuits.
- Patients that require direct admission to the intensive care unit (ICU) are also excluded as they do not transit through the recovery area.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Singapore5 sites
Singapore General Hospital
Singapore, 169608
KK Women's and Children's Hospital
Singapore, 229899
Tan Tock Seng Hospital
Singapore, 308433
Changi General Hospital
Singapore, 529889
Khoo Teck Phuat Hospital
Singapore, 768828
About this study
Aims:-
Primary:
To identify the incidence of intra-operative and post-operative hypothermia
Secondary:
To identify factors contributing to peri-operative hypothermia. To identify current anaesthetic practice in peri-operative temperature monitoring, use of active/warming measures by anaesthetists in various hospitals.
To increase awareness of the problem of IPH and guidelines available.
Read the detailed description
Inadvertent peri-operative hypothermia (IPH) affects patients across all ages, occurring up to 50% in the unwarmed surgical patient. It carries significant morbidity and mortality including increased risk of myocardial infarction, bleeding, and surgical site infection, increased shivering and patient discomfort, as well as increased length of hospital stay. Guidelines have been published by the UK National Institute for Clinical Excellence (NICE) as well as the American Society of Anaesthesiologists. However, the compliance to such guidelines have been poor, and no local guidelines have been developed as yet.
A one month audit was conducted in KKH Department of Paediatric Anaesthesia in 2014 which collected data on the incidence of perioperative hypothermia in patients undergoing general anaesthesia for a variety of surgeries. This preliminary audit demonstrated a 33.7% incidence of hypothermia in PACU among 164 patients.
The investigators wish to carry out a more comprehensive audit to find out the incidence of IPH in both adult and paediatric surgical patients, identify risk factors and assess the current practice to prevent IPH across various healthcare institutions.
The study aims to find out the incidence of IPH, identify the risk factors involved and find out the current preventive measures in various local hospitals; if not already in place, bring awareness to this problem and improve patient outcomes. This is a cross-sectional observational study, aiming to recruit 4000 patients of all ages, across 5 institutions over the course of 6 months.
Patients will receive the current standard of care, as per the anaesthetist in charge, with regards to temperature monitoring, and the use of passive/active warming strategies. The method of temperature monitoring, warming or heat conservation techniques would be recorded and the patient's temperature would be measured at the recovery area post-operatively by the recovery nurse. In addition, patient demographics, surgical time, anaesthetic time, surgical procedure and method of anaesthetic, total fluids given, will also be recorded on a prospectively-designed data collection form.
- Conditions
- Disturbance; Temperature Regulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hypothermia defined as core temperature<36 degrees Celsius
Mode of monitoring:
naso/oropharyngeal/rectal temperatures for intra-opt tympanic membrane /infra-red scanner for post-opt
Measured: Single core temperature recorded within 15 minutes upon arrival in PACU by the recovery nurse. Measurements will be taken for all recruited patients during the study period at each site.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startOct 2015
- Primary completionMar 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disturbance; Temperature RegulationStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shu Ying Lee, Mmed, FANZCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081000
- Sponsor's protocol ID
- CIRB2015/2817
- Status last verified
- Aug 2017
- First submitted
- 14 Jun 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hypothermia: A Multi-center Study of Incidence, Risk Factors and Preventive Measures.
- ClinicalTrials.gov ID
- NCT03081000
- Acronym / sponsor ID
- CIRB2015/2817
- Conditions
- Disturbance; Temperature Regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 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.
Aims:-
Primary:
To identify the incidence of intra-operative and post-operative hypothermia
Secondary:
To identify factors contributing to peri-operative hypothermia. To identify current anaesthetic practice in peri-operative temperature monitoring, use of active/warming measures by anaesthetists in various hospitals.
To increase awareness of the problem of IPH and guidelines available.
Detailed description
Inadvertent peri-operative hypothermia (IPH) affects patients across all ages, occurring up to 50% in the unwarmed surgical patient. It carries significant morbidity and mortality including increased risk of myocardial infarction, bleeding, and surgical site infection, increased shivering and patient discomfort, as well as increased length of hospital stay. Guidelines have been published by the UK National Institute for Clinical Excellence (NICE) as well as the American Society of Anaesthesiologists. However, the compliance to such guidelines have been poor, and no local guidelines have been developed as yet.
A one month audit was conducted in KKH Department of Paediatric Anaesthesia in 2014 which collected data on the incidence of perioperative hypothermia in patients undergoing general anaesthesia for a variety of surgeries. This preliminary audit demonstrated a 33.7% incidence of hypothermia in PACU among 164 patients.
The investigators wish to carry out a more comprehensive audit to find out the incidence of IPH in both adult and paediatric surgical patients, identify risk factors and assess the current practice to prevent IPH across various healthcare institutions.
The study aims to find out the incidence of IPH, identify the risk factors involved and find out the current preventive measures in various local hospitals; if not already in place, bring awareness to this problem and improve patient outcomes. This is a cross-sectional observational study, aiming to recruit 4000 patients of all ages, across 5 institutions over the course of 6 months.
Patients will receive the current standard of care, as per the anaesthetist in charge, with regards to temperature monitoring, and the use of passive/active warming strategies. The method of temperature monitoring, warming or heat conservation techniques would be recorded and the patient's temperature would be measured at the recovery area post-operatively by the recovery nurse. In addition, patient demographics, surgical time, anaesthetic time, surgical procedure and method of anaesthetic, total fluids given, will also be recorded on a prospectively-designed data collection form.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a prospective cross-sectional observational study, aiming to recruit 4000 patients of all ages, going for surgery (day surgery/inpatient, elective/emergency). , not involving the use of extra-corporeal circuits, across 5 institutions (KKWCH, CGH, SGH, TTSH, KTPH) over the course of 6 months (oct 2015 to Mar 2016).Recruitment will be done over 1-2 months period at each site by 3 co-Investigators as they rotate through each of the anaesthetic department as part of their residency postings. A consultant site-Principal Investigator will be in charge of supervising the co-Investigators during the recruitment at each site.
Key inclusion criteria (1 listed)
- All cases within specified time frame under General anaesthesia (GA), Regional anaesthesia (RA), or combined General and Regional Anaesthesia (GA/RA) not involving the use of extra-corporeal circuits.
Key exclusion criteria (2 listed)
- Cases done under Monitored Anaesthesia Care (MAC) or that have the use of extracorporeal circuits.
- Patients that require direct admission to the intensive care unit (ICU) are also excluded as they do not transit through the recovery area.
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
Post-operative hypothermia defined as core temperature<36 degrees Celsius
Time frame: Single core temperature recorded within 15 minutes upon arrival in PACU by the recovery nurse. Measurements will be taken for all recruited patients during the study period at each site.
Mode of monitoring: naso/oropharyngeal/rectal temperatures for intra-opt tympanic membrane /infra-red scanner for post-opt
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 29 Aug 2017.
- Individual participant dataSharing planned: Undecided
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.
Shu Ying Lee, Mmed, FANZCA principal investigator
KK Women's and Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disturbance; Temperature Regulation, run by KK Women's and Children's Hospital at 5 sites in Singapore.
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: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore. 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?
Post-operative hypothermia defined as core temperature<36 degrees Celsius (time frame: Single core temperature recorded within 15 minutes upon arrival in PACU by the recovery nurse. Measurements will be taken for all recruited patients during the study period at each site.). 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 29 Aug 2017.