HypothermiaNCT03184506
Effect of Pre-warming on Perioperative Hypothermia During HoLEPunder Spinal Anesthesia
A study testing pre-warming and no warming in people with Hypothermia, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below 36°C. Intraoperative hypothermia can lead to serious clinical complications such as, myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Hypothermia
- What is being tested?
- pre-warming and no warming
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2017to 31 Dec 2017
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with ASA physical status I-III, aged 50 - 80 years, undergoing HoLEP under spinal anesthesia
Who cannot join
- preoperative body temperature of more than 37.2°C preexisting severe cardiovascular, respiratory and endocrinal disease on anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kangnam Sared heart Hospital
Seoul, Yeongdeungpo-gu, 07441
About this study
Official title: Effect of Pre-warming on Perioperative Hypothermia and Shivering During Holmium Laser Enucleation of the Prostate (HoLEP) Under Spinal Anesthesia
Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below 36°C. Intraoperative hypothermia can lead to serious clinical complications such as, myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection. Hypothermia develops easily during surgeries that require irrigation fluid, such as laparoscopic surgery and transurethral resection of the prostate. Although isothermic irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to warm a large volume of irrigation fluid.
Re-distribution after induction of anesthesia is the most important cause of perioperative hypothermia. The extent of re-distribution is proportional to the gradient between the core and peripheral compartments. Pre-warming increases the heat content of the peripheral thermal compartment, reducing the gradient for redistribution. Recently, A recent-meta analysis suggested that as a single strategy, preoperative forced air warming had significant benefits than other warming methods. Also, it was reported that only 20 (or even 10) min of pre-warming mostly prevented patients from perioperative hypothermia under general anesthesia. However, few studies have examined whether short time pre-warming can reduce hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia.
The purpose of this study is to assess whether the application of preoperative forced air warming set to high temperature (> 43°C) for brief period can prevent hypothermia or shivering during procedures requiring large volumes of cold irrigation.
- Conditions
- Hypothermia
- Being tested
- pre-warming, no warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-warmingOther
On arrival at the preoperative care unit, assignments were determined using an opaque sealed envelope opened by investigator with no clinical involvement in the study. In the pre-warming group, the forced-air blanket (COVIDIEN™ WarmTouch™ Full Body/Multi Access Blanket, Covidien Ilc, Mansfield, MA, USA) was positioned over the whole body except head and neck, covered by cotton blanket. Forced air warmer (COVIDIEN™ WarmTouch™ WT6000 Warming Unit, Covidien Ilc, Mansfield, MA, USA) was set to 'high level' (45℃) during 20 min. During the warming procedure, patients were asked every 5 min about their thermal comfort; if they felt overheated, the warmer was lowered to 41℃
no warmingOther
patients were covered only with two layers of cotton blanket
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | Not described Receives: Other: no warming |
| pre-warming group | Active comparator | Not described Receives: Other: pre-warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
core temperature
taken in the same ear using an infrared tympanic thermometer (ThermoScan IRT 1020; Braun, Germany), and the highest reading from three consecutive measurements was recorded.
Measured: on admission to PACU
Secondary outcomes (4)
the incidence of perioperative hypothermia
Hypothermia defined as a core temperature less than 36.0°C in according to the current guideline. The number of patients who became hypothermic at each time was recorded.
Measured: at baseline (preoperative care unit), on arrival at the OR, every 10 minutes after spinal anesthesia, and on admission to PACU 1 hour
the incidence of shivering
graded using 4 point scale (0 = no shivering; 1 = shivering localized to the core and neck; 2 = shivering including the upper extremities; and 3 = total body shivering)
Measured: on arrival at the OR, at every 30 minutes after spinal anesthesia, on admission to PACU, and then every 30 minutes for 1 hour.
Thermal comfort
evaluated using a numeric rating scale: 0 was defined as 'extremely cold', 5 as 'thermally neutral', and 10 as 'extremely hot'
Measured: on arrival at the OR, at every 30 minutes after spinal anesthesia, on admission to PACU, and then every 30 minutes for 1 hour.
core temperature
taken in the same ear using an infrared tympanic thermometer (ThermoScan IRT 1020; Braun, Germany), and the highest reading from three consecutive measurements was recorded.
Measured: at baseline (preoperative care unit), on arrival at the operation room, every 30 minutes after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start12 Jun 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun joohyun, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184506
- Sponsor's protocol ID
- 2017-05-002
- Status last verified
- Jun 2017
- First submitted
- 5 Jun 2017
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jun JH, Chung MH, Kim EM, Jun IJ, Kim JH, Hyeon JS, Lee MH, Lee HS, Choi EM. Effect of pre-warming on perioperative hypothermia during holmium laser enucleation of the prostate under spinal anesthesia: a prospective randomized controlled trial. BMC Anesthesiol. 2018 Dec 22;18(1):201. doi: 10.1186/s12871-018-0668-4.
PubMed 30579334
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-warming on Perioperative Hypothermia and Shivering During Holmium Laser Enucleation of the Prostate (HoLEP) Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03184506
- Acronym / sponsor ID
- 2017-05-002
- Conditions
- Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Jun 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.
Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below 36°C. Intraoperative hypothermia can lead to serious clinical complications such as, myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection. Hypothermia develops easily during surgeries that require irrigation fluid, such as laparoscopic surgery and transurethral resection of the prostate. Although isothermic irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to warm a large volume of irrigation fluid.
Re-distribution after induction of anesthesia is the most important cause of perioperative hypothermia. The extent of re-distribution is proportional to the gradient between the core and peripheral compartments. Pre-warming increases the heat content of the peripheral thermal compartment, reducing the gradient for redistribution. Recently, A recent-meta analysis suggested that as a single strategy, preoperative forced air warming had significant benefits than other warming methods. Also, it was reported that only 20 (or even 10) min of pre-warming mostly prevented patients from perioperative hypothermia under general anesthesia. However, few studies have examined whether short time pre-warming can reduce hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia.
The purpose of this study is to assess whether the application of preoperative forced air warming set to high temperature (> 43°C) for brief period can prevent hypothermia or shivering during procedures requiring large volumes of cold irrigation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Other: no warming |
| pre-warming group | Active comparator | Other: pre-warming |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with ASA physical status I-III, aged 50 - 80 years, undergoing HoLEP under spinal anesthesia
Key exclusion criteria (1 listed)
- preoperative body temperature of more than 37.2°C preexisting severe cardiovascular, respiratory and endocrinal disease on anticoagulant therapy
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 |
|---|---|---|
| pre-warmingOn arrival at the preoperative care unit, assignments were determined using an opaque sealed envelope opened by investigator with no clinical involvement in the study. In the pre-warming group, the forced-air blanket (COVIDIEN™ WarmTouch™ Full Body/Multi Access Blanket, Covidien Ilc, Mansfield, MA, USA) was positioned over the whole body except head and neck, covered by cotton blanket. Forced air warmer (COVIDIEN™ WarmTouch™ WT6000 Warming Unit, Covidien Ilc, Mansfield, MA, USA) was set to 'high level' (45℃) during 20 min. During the warming procedure, patients were asked every 5 min about their thermal comfort; if they felt overheated, the warmer was lowered to 41℃ | Other | pre-warming group |
| no warmingpatients were covered only with two layers of cotton blanket | Other | control group |
Primary outcome
core temperature
Time frame: on admission to PACU
taken in the same ear using an infrared tympanic thermometer (ThermoScan IRT 1020; Braun, Germany), and the highest reading from three consecutive measurements was recorded.
4 secondary outcomes
the incidence of perioperative hypothermia
Time frame: at baseline (preoperative care unit), on arrival at the OR, every 10 minutes after spinal anesthesia, and on admission to PACU 1 hour
the incidence of shivering
Time frame: on arrival at the OR, at every 30 minutes after spinal anesthesia, on admission to PACU, and then every 30 minutes for 1 hour.
Thermal comfort
Time frame: on arrival at the OR, at every 30 minutes after spinal anesthesia, on admission to PACU, and then every 30 minutes for 1 hour.
core temperature
Time frame: at baseline (preoperative care unit), on arrival at the operation room, every 30 minutes after spinal anesthesia
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 4 Mar 2019.
- Derived from this study: PubMed 30579334Jun JH, Chung MH, Kim EM, Jun IJ, Kim JH, Hyeon JS, Lee MH, Lee HS, Choi EM. Effect of pre-warming on perioperative hypothermia during holmium laser enucleation of the prostate under spinal anesthesia: a prospective randomized controlled trial. BMC Anesthesiol. 2018 Dec 22;18(1):201. doi: 10.1186/s12871-018-0668-4.
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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?
A study testing pre-warming and no warming in people with Hypothermia, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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 1 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 4 Mar 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
core temperature (time frame: on admission to PACU). 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 NCT03184506, which also lists 1 linked publication.
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 4 Mar 2019.