Hypothermia; AnesthesiaNCT04252820
Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
A study testing WarmTouch total body blanket, Covidien Ltd, Mansfield, USA in people with Hypothermia; Anesthesia and Perioperative Complication, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial summary
Perioperative hypothermia is one of the most common anaesthetic complications, increasing the morbidity/mortality of our patients. Active prewarming with hot forced-air devices has demonstrated to be the most effective tool to prevent hypothermia, but its use is only recommended in long-term surgeries and the optimal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia; Anesthesia, Perioperative Complication, Regional Anesthesia Morbidity
- What is being tested?
- WarmTouch total body blanket, Covidien Ltd, Mansfield, USA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 4 Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective Transurethral resection under spinal anesthesia.
- Patients older tan 18 years old.
- American Society of Anesthesiologists physical status classification I - III.
- Absence of cognitive impairment.
- Written informed consent before enrollment.
Who cannot join
- Pregnancy.
- American Society of Anesthesiologists physical status classification IV.
- Active infection.
- Intake of antipyretics within 24 hours before surgery.
- Thyroid disorders.
- Skin lesions or History of hypersensitivity to skin contact devices.
Trial locations and contacts
1 site in 1 country.
About this study
Perioperative hypothermia is one of the most common anaesthetic complications, increasing the morbidity/mortality of our patients. Active prewarming with hot forced-air devices has demonstrated to be the most effective tool to prevent hypothermia, but its use is only recommended in long-term surgeries and the optimal prewarming duration has not been elucidated. Both spinal anaesthesia associated to the irrigation with liquids at low temperature instilled during transurethral resection (TUR) cause a decrease in the core temperature of the patient. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. Our aim is to assess the effect of different time-periods of prewarming on preventing perioperative hypothermia during TUR with spinal anaesthesia. Investigators will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 200 patients are going to be included in this study (50 patients in each group). Measurement of temperature will be performed using a tympanic thermometer and zero-heat-flux temperature sensor. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.
Read the detailed description
Inadvertent perioperative hypothermia is probably the most common anaesthetic complication. Its appearance increases the morbidity of the surgical patient, increasing the incidence of cardiac events or perioperative blood loss and causes a greater time of recovery from anaesthesia. Prewarming is the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, prewarming in patients submitted to spinal anesthesia is still a weak recommendation and the optimal prewarming time has not been elucidated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection under spinal anaesthesia, the conductance of this clinical trial is justified.
- Conditions
- Hypothermia; Anesthesia, Perioperative Complication, Regional Anesthesia Morbidity, Temperature Change, Body, Transurethral Resection Syndrome
- Being tested
- WarmTouch total body blanket, Covidien Ltd, Mansfield, USA
- Keywords
- body temperature, hypothermia, prewarming, regional anesthesia
- Medical subject headings
- Hypothermia, Body Temperature Changes, Transurethral resection syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarmTouch total body blanket, Covidien Ltd, Mansfield, USADevice
Forced-air warming will be applied in the preanesthetic room
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No prewarming. Patients will be actively warmed during the intraoperative period. Tympanic thermometer and zero-heat-flux temperature sensor will be used to measure the temperature throughout the perioperative period. |
| Prewarming during 15 minutes | Experimental | Active Prewarming will be performed during 15 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period. Receives: Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA |
| Prewarming during 30 minutes | Experimental | Active Prewarming will be performed during 30 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period. Receives: Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA |
| Prewarming during 45 minutes | Experimental | Active Prewarming will be performed during 45 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period. Receives: Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor
To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection under spinal anesthesia
Measured: Throughout surgery, an average of 60 minutes.
Secondary outcomes (3)
Length of stay in postanesthetic care unit (in minutes)
To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection under spinal anesthesia.
Measured: Stay in Post-Anesthetic Care Unit, an average of 6 hours.
Postoperative pain, using visual analogue scale (from 0 to 10)
To assess the effect of prewarming in reducing the postoperative pain at the arrival to the postanesthetic care unit of patients undergoing elective transurethral resection under spinal anesthesia
Measured: Immediate postoperative period, an average of 1 hour.
Postoperative shivering (using a dichotomous scale: yes or no)
To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection under spinal anesthesia
Measured: Immediate postoperative period, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Mar 2020
- Primary completion4 Aug 2020
- Study completion4 Aug 2020
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
- Model description
- Different time periods of prewarming will be compared: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Aurelio Rodríguez-Pérez, PhD, Study director, Dr Negrin UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252820
- Sponsor's protocol ID
- RTU-Spinal
- Status last verified
- Aug 2020
- First submitted
- 31 Jan 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT04252820
- Acronym / sponsor ID
- RTU-Spinal
- Conditions
- Hypothermia; Anesthesia, Perioperative Complication, Regional Anesthesia Morbidity, Temperature Change, Body, Transurethral Resection Syndrome
- Keywords
- body temperature, hypothermia, prewarming, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 5 Feb 2020 (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.
Perioperative hypothermia is one of the most common anaesthetic complications, increasing the morbidity/mortality of our patients. Active prewarming with hot forced-air devices has demonstrated to be the most effective tool to prevent hypothermia, but its use is only recommended in long-term surgeries and the optimal prewarming duration has not been elucidated. Both spinal anaesthesia associated to the irrigation with liquids at low temperature instilled during transurethral resection (TUR) cause a decrease in the core temperature of the patient. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. Our aim is to assess the effect of different time-periods of prewarming on preventing perioperative hypothermia during TUR with spinal anaesthesia. Investigators will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 200 patients are going to be included in this study (50 patients in each group). Measurement of temperature will be performed using a tympanic thermometer and zero-heat-flux temperature sensor. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.
Detailed description
Inadvertent perioperative hypothermia is probably the most common anaesthetic complication. Its appearance increases the morbidity of the surgical patient, increasing the incidence of cardiac events or perioperative blood loss and causes a greater time of recovery from anaesthesia. Prewarming is the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, prewarming in patients submitted to spinal anesthesia is still a weak recommendation and the optimal prewarming time has not been elucidated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection under spinal anaesthesia, the conductance of this clinical trial is justified.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
- Model description
- Different time periods of prewarming will be compared: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No prewarming. Patients will be actively warmed during the intraoperative period. Tympanic thermometer and zero-heat-flux temperature sensor will be used to measure the temperature throughout the perioperative period. |
| Prewarming during 15 minutes | Experimental | Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USAActive Prewarming will be performed during 15 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period. |
| Prewarming during 30 minutes | Experimental | Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USAActive Prewarming will be performed during 30 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period. |
| Prewarming during 45 minutes | Experimental | Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USAActive Prewarming will be performed during 45 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing elective Transurethral resection under spinal anesthesia.
- Patients older tan 18 years old.
- American Society of Anesthesiologists physical status classification I - III.
- Absence of cognitive impairment.
- Written informed consent before enrollment.
Key exclusion criteria (6 listed)
- Pregnancy.
- American Society of Anesthesiologists physical status classification IV.
- Active infection.
- Intake of antipyretics within 24 hours before surgery.
- Thyroid disorders.
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 |
|---|---|---|
| WarmTouch total body blanket, Covidien Ltd, Mansfield, USAForced-air warming will be applied in the preanesthetic room | Device | Prewarming during 15 minutes, Prewarming during 30 minutes, Prewarming during 45 minutes |
Primary outcome
Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor
Time frame: Throughout surgery, an average of 60 minutes.
To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection under spinal anesthesia
3 secondary outcomes
Length of stay in postanesthetic care unit (in minutes)
Time frame: Stay in Post-Anesthetic Care Unit, an average of 6 hours.
Postoperative pain, using visual analogue scale (from 0 to 10)
Time frame: Immediate postoperative period, an average of 1 hour.
Postoperative shivering (using a dichotomous scale: yes or no)
Time frame: Immediate postoperative period, an average of 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 6 Aug 2020.
- Individual participant dataSharing planned: No. Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.
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
Shivering, Postoperative Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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Recruiting
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.
Aurelio Rodríguez-Pérez, PhD study director
Dr Negrin UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WarmTouch total body blanket, Covidien Ltd, Mansfield, USA in people with Hypothermia; Anesthesia and Perioperative Complication, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
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 5 inclusion and 6 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 6 Aug 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 Spain. 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?
Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor (time frame: Throughout surgery, an average of 60 minutes.). 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 6 Aug 2020.