Hypothermia; AnesthesiaNCT03617809
Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery
An observational study of Hypothermia; Anesthesia and Anesthesia; Adverse Effect, run by Ángel Becerra at 1 site in Spain.
Trial summary
Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as perioperative bleeding or surgical site infection. Once the temperature has decreased, its treatment is difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia; Anesthesia, Anesthesia; Adverse Effect, Peroperative Complication
- What is being tested?
- Preoperative warming
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- 1 siteSpain
- Study dates
- 6 Aug 2018to 24 Oct 2019
- How long will I take part?
- 15 Days
- 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: This is an observational prospective study comparing routine practice of prewarming in consecutive surgical patients scheduled to undergo elective laparoscopic urological surgery between August and December 2018. Ninety-nine patients will be included in this study and prewarming will be applied following routine clinical practice. The prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room.
Who may be able to join
- Patients undergoing elective laparoscopic urological surgery under general anesthesia.
Who cannot join
- Active infection
- Intake of antipyretics within 24 hours before surgery
- Neuropathy
- Thyroid disorders
- Peripheral vascular disease
- Skin lesions
- History of hypersensitivity to skin contact devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery
Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as perioperative bleeding or surgical site infection. Once the temperature has decreased, its treatment is difficult.
Preoperative warming prevents hypothermia, lowering the temperature gradient between core and peripheral compartments and reducing thermal redistribution. The most recent clinical practice guidelines advocate for active prewarming before induction of general anaesthesia since it is very effective in preventing perioperative hypothermia. However, the ideal warming time prior to the induction of anesthesia has long been investigated. This study aims to evaluate if different time periods of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery in patients submitted to laparoscopic urological surgery under general anesthesia. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to laparoscopic prostatectomy or nephrectomy between August and December 2018. In this study 64 - 96 patients will be included and prewarming will be applied following routine clinical practice. The prewarming time will depend on the time the patient has to wait before entering in the operating theatre. Measurement of temperature will be performed using an esophagic thermometer. 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
Maintaining patient's temperature above 36 grades Celsius throughout the perioperative period is challenging. Thus, it is essential to monitor temperature in order to be able to take measures to avoid the appearance of hypothermia. Once the temperature has decreased, its treatment is difficult since the application of heat to the body surface takes a long time to reach the core thermal compartment. Intraoperative warming alone cannot avoid postoperative hypothermia. The application of forced-air warming system during the preoperative period has been shown to be the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, long time periods of prewarming would not be efficient. Thus, the ideal warming time prior to the induction of anesthesia has long been investigated.
Due to the searching of optimal prewarming time, the conductance of this study is justified.
- Conditions
- Hypothermia; Anesthesia, Anesthesia; Adverse Effect, Peroperative Complication, Postoperative Complications, Surgical Site Infection, Temperature Change, Body
- Being tested
- Preoperative warming
- Keywords
- Prewarming, Perioperative hypothermia, Esophageal thermometer
- Medical subject headings
- Hypothermia, Intraoperative Complications, Postoperative Complications, Surgical Wound Infection, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative warmingProcedure or surgery
The prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Prewarming | Active Prewarming will be performed using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be warmed using a surgical blanket during the intraoperative period. Esophageal thermometer will be used to measure the temperature throughout the intraoperative period. Receives: Procedure: Preoperative warming | |
| Control | Non-active prewarming. Patients will be warmed using a surgical blanket during the intraoperative period. Esophageal thermometer will be used to measure the temperature throughout the intraoperative period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Asses the effect of prewarming in maintaining body temperature of patients undergoing elective laparoscopic urological surgery.
Measured: Through perioperative period, an average of 7 hours
Temperature
Differences in body core temperature throughout the perioperative period among different groups
Measured: From the arrival to the pre-anesthesia room to one hour after the arrival to the postanesthetic care unit an average of 7 hours.
Secondary outcomes (5)
Surgical site infection
Asses the effect of prewarming in preventing surgical site infection of patients undergoing elective laparoscopic urological surgery.
Measured: Through patient's stay in hospital, an average of 15 days
Postoperative shivering (using a dichotomous scale: yes or no)
To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing laparoscopic urological surgery.
Measured: Immediate postoperative period, an average of 1 hour.
Risk factors of perioperative hypothermia
To assess the effect of perioperative factors, related to the characteristics of patients and the surgery on provoking a greater drop of perioperative temperature.
Measured: Throughout the perioperative period, an average of 7 hours.
Perioperative bleeding
Asses the effect of prewarming on decreasing perioperative bleeding of patients undergoing elective laparoscopic urological surgery.
Measured: Throughout the perioperative period, an average of 7 hours.
Postoperative pain, using the visual analogue scale, from 0 to 10
Asses the effect of prewarming on decreasing postoperative pain of patients undergoing elective laparoscopic urological surgery.
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 posted6 Aug 2018
- Study start6 Aug 2018
- Primary completion24 Oct 2019
- Study completion24 Oct 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Ángel Becerra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Las Palmas de Gran Canaria
- Responsible party
- Sponsor-investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ángel Becerra, MD, Principal investigator, Doctor Negrin University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617809
- Sponsor's protocol ID
- 2018-089-1
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD 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 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery
- ClinicalTrials.gov ID
- NCT03617809
- Acronym / sponsor ID
- 2018-089-1
- Conditions
- Hypothermia; Anesthesia, Anesthesia; Adverse Effect, Peroperative Complication, Postoperative Complications, Surgical Site Infection, Temperature Change, Body
- Keywords
- Prewarming, Perioperative hypothermia, Esophageal thermometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ángel BecerraUniversity, hospital or other
- Collaborators
- University of Las Palmas de Gran Canaria
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 6 Aug 2018 (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.
Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as perioperative bleeding or surgical site infection. Once the temperature has decreased, its treatment is difficult.
Preoperative warming prevents hypothermia, lowering the temperature gradient between core and peripheral compartments and reducing thermal redistribution. The most recent clinical practice guidelines advocate for active prewarming before induction of general anaesthesia since it is very effective in preventing perioperative hypothermia. However, the ideal warming time prior to the induction of anesthesia has long been investigated. This study aims to evaluate if different time periods of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery in patients submitted to laparoscopic urological surgery under general anesthesia. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to laparoscopic prostatectomy or nephrectomy between August and December 2018. In this study 64 - 96 patients will be included and prewarming will be applied following routine clinical practice. The prewarming time will depend on the time the patient has to wait before entering in the operating theatre. Measurement of temperature will be performed using an esophagic thermometer. 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
Maintaining patient's temperature above 36 grades Celsius throughout the perioperative period is challenging. Thus, it is essential to monitor temperature in order to be able to take measures to avoid the appearance of hypothermia. Once the temperature has decreased, its treatment is difficult since the application of heat to the body surface takes a long time to reach the core thermal compartment. Intraoperative warming alone cannot avoid postoperative hypothermia. The application of forced-air warming system during the preoperative period has been shown to be the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, long time periods of prewarming would not be efficient. Thus, the ideal warming time prior to the induction of anesthesia has long been investigated.
Due to the searching of optimal prewarming time, the conductance of this study is justified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prewarming | – | Procedure: Preoperative warmingActive Prewarming will be performed using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be warmed using a surgical blanket during the intraoperative period. Esophageal thermometer will be used to measure the temperature throughout the intraoperative period. |
| Control | – | –Non-active prewarming. Patients will be warmed using a surgical blanket during the intraoperative period. Esophageal thermometer will be used to measure the temperature throughout the intraoperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational prospective study comparing routine practice of prewarming in consecutive surgical patients scheduled to undergo elective laparoscopic urological surgery between August and December 2018. Ninety-nine patients will be included in this study and prewarming will be applied following routine clinical practice. The prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room.
Key inclusion criteria (1 listed)
- Patients undergoing elective laparoscopic urological surgery under general anesthesia.
Key exclusion criteria (7 listed)
- Active infection
- Intake of antipyretics within 24 hours before surgery
- Neuropathy
- Thyroid disorders
- Peripheral vascular 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 |
|---|---|---|
| Preoperative warmingThe prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room. | Procedure or surgery | Prewarming |
Primary outcome
Temperature
Time frame: Through perioperative period, an average of 7 hours
Asses the effect of prewarming in maintaining body temperature of patients undergoing elective laparoscopic urological surgery.
Temperature
Time frame: From the arrival to the pre-anesthesia room to one hour after the arrival to the postanesthetic care unit an average of 7 hours.
Differences in body core temperature throughout the perioperative period among different groups
5 secondary outcomes
Surgical site infection
Time frame: Through patient's stay in hospital, an average of 15 days
Postoperative shivering (using a dichotomous scale: yes or no)
Time frame: Immediate postoperative period, an average of 1 hour.
Risk factors of perioperative hypothermia
Time frame: Throughout the perioperative period, an average of 7 hours.
Perioperative bleeding
Time frame: Throughout the perioperative period, an average of 7 hours.
Postoperative pain, using the visual analogue scale, from 0 to 10
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 9 Jul 2020.
- Individual participant dataSharing planned: Undecided. IPD 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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Not yet recruitingPhase 4
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.
Ángel Becerra, MD principal investigator
Doctor Negrin University 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; Anesthesia and Anesthesia; Adverse Effect, run by Ángel Becerra 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 1 inclusion and 7 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 9 Jul 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?
Temperature (time frame: Through perioperative period, an average of 7 hours). The study lists 2 primary outcomes in all. 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 9 Jul 2020.