Hypothermia; AnesthesiaNCT04027842
Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia
A study testing Prewarming in people with Hypothermia; Anesthesia, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial summary
Previous research has shown beneficial effects of prewarming on preventing inadvertent perioperative hypothermia (IPH). Warming the surface of the body before the induction of anesthesia can reduce the temperature difference between the core and periphery, thereby reducing the degree of core-to-peripheral thermal… Read more about this study
- Who is it for?
- Ages 19 to 75 years, women only
- Conditions the study is for
- Hypothermia; Anesthesia
- What is being tested?
- Prewarming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jan 2019to 30 Jun 2019
- 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 19 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1 or 2 patients
- patients who underwent gynecologic laparoscopic surgery under general anesthesia
Who cannot join
- preexisting hypothermia (<36℃) or hyperthermia (>37.5℃)
- anesthesia last for <1 hour or >2 hours
- conversion from laparoscopic surgery to laparotomy
- patients with a body mass index (BMI) ≥ 31kg/m2
- patients with known thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Previous research has shown beneficial effects of prewarming on preventing inadvertent perioperative hypothermia (IPH). Warming the surface of the body before the induction of anesthesia can reduce the temperature difference between the core and periphery, thereby reducing the degree of core-to-peripheral thermal redistribution. It has been proved that initiation of warming before surgery can be more useful for preventing IPH than warming only during surgery. Nevertheless, there are not many researches on effects of short period (<30 min) prewarming, especially in gynecologic laparoscopic surgery. Accordingly, the investigators designed this study to test if IPH can be effectively prevented when 10 minutes of prewarming is added to intraoperative active warming in patients undergoing gynecologic laparoscopic surgery.
- Conditions
- Hypothermia; Anesthesia
- Being tested
- Prewarming
- Keywords
- Perioperative hypothermia, Core body temperature, Prewarming, Gynecologic laparoscopic surgery
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrewarmingDevice
In the operating theater, participants allocated in Prewarming group received 10 min-prewarming, which is cutaneous warming before induction of anesthesia. For prewarming, forced air warming system (WarmTouch WT 6000 Warming Unit, Medtronic, Minneapolis, MN, USA) was used and the warming temperature of the device was set to 45°C.
| Study group | Role | What they receive |
|---|---|---|
| Prewarming group | Experimental | Participants in Prewarming group was warmed with forced air warming device (WarmTouch WT 6000 Warming Unit, Medtronic, Minneapolis, MN, USA) over the entire body for 10 minutes before anesthesia was induced in the operating theater. All participants received active warming with forced air warming system from the initiation of anesthetic induction until end of surgery. Receives: Device: Prewarming |
| Non-prewarming group | No intervention | In Non-prewarming group, no active warming was conducted before induction of anesthesia. Only standard care was provided with introperative active warming with forced air warming system from the initiation of anesthetic induction until end of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of intraoperative hypothermia
Number of Participants whose core temperature was than 36℃ was recorded at each time point.
Measured: on arrival at operating theater, before anesthesia induced, every 15 minutes after anesthetic induction until admission to the post anesthetic care unit (PACU)
Secondary outcomes (2)
the incidence of postoperative shivering
Number of Participants who suffer shivering at the post anesthetic care unit was recorded. Postoperative shivering was graded by an investigator who did not know the procedure in the operating room; shivering grade was divided into four grades (0 = none, 1 = mild, 2 = moderate, 3 = severe, The Bedside Shivering Assessment Scale)
Measured: on the admission to PACU, 30 minutes after the admission to PACU
Time-temperature interaction during the first 1 hour of anesthesia
Core body temperature was recorded at each time point. Time-temperature interaction of 2 groups during the first 1 hour of anesthesia was analyzed by RMANOVA
Measured: Core body temperature was recorded at 15-min intervals from initiation of anesthesia for 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start9 Jan 2019
- Primary completion19 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia; AnesthesiaStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yong Jung, Daegu Catholic University Medical Center
- Investigators
- Jin Yong Jung, MD, Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027842
- Sponsor's protocol ID
- CR-18-174
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04027842
- Acronym / sponsor ID
- CR-18-174
- Conditions
- Hypothermia; Anesthesia
- Keywords
- Perioperative hypothermia, Core body temperature, Prewarming, Gynecologic laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 22 Jul 2019 (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.
Previous research has shown beneficial effects of prewarming on preventing inadvertent perioperative hypothermia (IPH). Warming the surface of the body before the induction of anesthesia can reduce the temperature difference between the core and periphery, thereby reducing the degree of core-to-peripheral thermal redistribution. It has been proved that initiation of warming before surgery can be more useful for preventing IPH than warming only during surgery. Nevertheless, there are not many researches on effects of short period (<30 min) prewarming, especially in gynecologic laparoscopic surgery. Accordingly, the investigators designed this study to test if IPH can be effectively prevented when 10 minutes of prewarming is added to intraoperative active warming in patients undergoing gynecologic laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prewarming group | Experimental | Device: PrewarmingParticipants in Prewarming group was warmed with forced air warming device (WarmTouch WT 6000 Warming Unit, Medtronic, Minneapolis, MN, USA) over the entire body for 10 minutes before anesthesia was induced in the operating theater. All participants received active warming with forced air warming system from the initiation of anesthetic induction until end of surgery. |
| Non-prewarming group | No intervention | –In Non-prewarming group, no active warming was conducted before induction of anesthesia. Only standard care was provided with introperative active warming with forced air warming system from the initiation of anesthetic induction until end of surgery. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status 1 or 2 patients
- patients who underwent gynecologic laparoscopic surgery under general anesthesia
Key exclusion criteria (5 listed)
- preexisting hypothermia (<36℃) or hyperthermia (>37.5℃)
- anesthesia last for <1 hour or >2 hours
- conversion from laparoscopic surgery to laparotomy
- patients with a body mass index (BMI) ≥ 31kg/m2
- patients with known thyroid disease
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 |
|---|---|---|
| PrewarmingIn the operating theater, participants allocated in Prewarming group received 10 min-prewarming, which is cutaneous warming before induction of anesthesia. For prewarming, forced air warming system (WarmTouch WT 6000 Warming Unit, Medtronic, Minneapolis, MN, USA) was used and the warming temperature of the device was set to 45°C. | Device | Prewarming group |
Primary outcome
the incidence of intraoperative hypothermia
Time frame: on arrival at operating theater, before anesthesia induced, every 15 minutes after anesthetic induction until admission to the post anesthetic care unit (PACU)
Number of Participants whose core temperature was than 36℃ was recorded at each time point.
2 secondary outcomes
the incidence of postoperative shivering
Time frame: on the admission to PACU, 30 minutes after the admission to PACU
Time-temperature interaction during the first 1 hour of anesthesia
Time frame: Core body temperature was recorded at 15-min intervals from initiation of anesthesia for 1 hour.
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 22 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Hypothermia; Anesthesia
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Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
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Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
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Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal Shivering
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.
Jin Yong Jung, MD principal investigator
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prewarming in people with Hypothermia; Anesthesia, run by Daegu Catholic University Medical Center 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 2 inclusion and 5 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 22 Jul 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. 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 intraoperative hypothermia (time frame: on arrival at operating theater, before anesthesia induced, every 15 minutes after anesthetic induction until admission to the post anesthetic care unit (PACU)). 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 22 Jul 2019.