HypothermiaNCT05573152
Pre Warming Protocol Implementation in Operation Room
A study testing Nursing in people with Hypothermia, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Literature establishes that warming with a heated blanket before and during the operation is effective in the prevention of perioperative hypothermia, both in general anesthesia as well as spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Nursing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Feb 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults that will be submitted to general or spinal anesthesia in the surgical center of hospital central at Santa Casa de Misericórdia in São Paulo
Who cannot join
- Patient under 18 years old;
- Patients that are feverish/present with infectious symptoms
- Refusal of the use of the device by the patient
- Patient that does not tolerate the use of the blanket in the pre op.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Ciencias Medicas da Santa Casa de São Paulo
São Paulo, 01220-021
About this study
Official title: Pre Warming Protocol Implementation Strategy in the Operation Room Routine
Literature establishes that warming with a heated blanket before and during the operation is effective in the prevention of perioperative hypothermia, both in general anesthesia as well as spinal anesthesia. However, the trials have still not presented us with objective protocols to standardize this routine in the surgical centers.
The study aims to assess the adoption and reproduction of the implementation of the warning device by the nursing team immediately after the patient's entrance in the operating room, even before the entrance of the anesthesiologist.
Read the detailed description
After approval by the Institutional Research Ethics Committee, the patients for elective surgeries to be submitted to general and spinal anesthesia lasting 60 minutes or more held at the central operating center at Santa Casa de Misericórdia in São Paulo will be assessed over a period of 60 days. The patients will receive the necessary explanations on the research and, after obtaining the responsible consent for participating in the trial, they will be included.
Inclusion/exclusion criteria:
Inclusion - adults that will be submitted to general or spinal anesthesia in the central operating center at Santa Casa de Misericórdia in São Paulo.
Exclusion:
- Patient over 18 years old;
- Patients that are feverish/present with infectious symptoms
- Refusal of the use of the device by the patient
- Patient that does not tolerate the use of the blanket in the pre op. The study aims to assess over a period of 60 days the compliance to the protocol and the prewarming time with the use of the heated air flow device from the moment the patients enter the operating room until anesthesia induction. The heating device will be set up connected to the patient and to the motor with the activation of the system at 43°C by the nursing team. The monitoring of the times since the entrance of the patient in the operating room until the induction of the anesthesia will be controlled by a member of the anesthesia team (regardless of the room process).
All the patients scheduled with elective surgery predicted to last over 60 minutes will be selected and there will be an assessment of the number of cases in which the protocol was followed and the time of use of the warming device will be monitored from the installation entrance in the OR and before the anesthesia induction and every 30 minutes beginning of anesthesia, during the surgery until the end of the anesthetic procedure.
The variables to be assessed in the study are:
- Age, gender, weight, height, body mass index (BMI), diseases, physical condition according to the American Anesthesiology Association classification;
- Oral temperature measured at the following points:
- M-entrance - entering the room and installation of the blanket
- M-ind - from the moment after the induction of anesthesia;
- M30, M60, M90, M120 = 30, 60, 90, 120 min after induction till the end of the anesthetic procedure; and the patients scheduled to general anesthesia will be also measured with esophagus thermometer
- The protocol establishes the types of warm blankets available to be used for the different types of surgery;
- Arterial oxygen saturation; heart beat; systolic and diastolic pressure and carbon dioxide expired:
- At the entrance of the operating room;
- Immediately after induction;
- Every 30 minutes after induction until the patient leaves the operating room;
- The type of surgery and anesthesia will be assessed among the pre-warming groups
- Room temperature will be measured (at the entrance of the patient and after induction and at the end of surgery/anesthesia;
- Presence of side effects. The need of blood transfusion will be assessed during surgery. There will be statistical assessment of the results, the significant statistical difference will be p<0.05.
- Conditions
- Hypothermia
- Being tested
- Control, Nursing
- Keywords
- Body Temperature, Hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
All previously selected patients will be under passive warming by means of blankets
NursingProcedure or surgery
All previously selected patients will be under active air flow warming device at 43 Celsius
| Study group | Role | What they receive |
|---|---|---|
| Nursing | Experimental | Nursing Group (Nurse): the nursing team will use of the warming device air flow device from the moment the patients enter the operating room until anesthesia induction. The warming device will be set up connected to the patient and to the motor with the activation of the system at 43°C by the nursing team. The monitoring of the times since the entrance of the patient in the operating room until the induction of the anesthesia will be controlled by a member of the anesthesia team (regardless of the room process); Receives: Procedure: Control; Procedure: Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
temperature from entrance in surgical room to ending of anesthesia state
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Caio G De Bernardis, MD, Ph.D, Principal investigator, Irmandade Santa Casa deMisericórdia de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573152
- Sponsor's protocol ID
- Parecer 699.971
- Status last verified
- Oct 2022
- First submitted
- 17 Jun 2015
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Vaughan MS, Vaughan RW, Cork RC. Postoperative hypothermia in adults: relationship of age, anesthesia, and shivering to rewarming. Anesth Analg. 1981 Oct;60(10):746-51.
PubMed 7197479Sessler DI. Perioperative thermoregulation and heat balance. Ann N Y Acad Sci. 1997 Mar 15;813:757-77. doi: 10.1111/j.1749-6632.1997.tb51779.x.
PubMed 9100967Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.
PubMed 7879936Hynson JM, Sessler DI, Glosten B, McGuire J. Thermal balance and tremor patterns during epidural anesthesia. Anesthesiology. 1991 Apr;74(4):680-90. doi: 10.1097/00000542-199104000-00011.
PubMed 2008950Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.
PubMed 7879935Hendolin H, Lansimies E. Skin and central temperatures during continuous epidural analgesia and general anaesthesia in patients subjected to open prostatectomy. Ann Clin Res. 1982 Aug;14(4):181-6.
PubMed 7168548Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
PubMed 17342966Kurz A, Sessler DI, Christensen R, Dechert M. Heat balance and distribution during the core-temperature plateau in anesthetized humans. Anesthesiology. 1995 Sep;83(3):491-9. doi: 10.1097/00000542-199509000-00007.
PubMed 7661349Hynson JM, Sessler DI, Moayeri A, McGuire J, Schroeder M. The effects of preinduction warming on temperature and blood pressure during propofol/nitrous oxide anesthesia. Anesthesiology. 1993 Aug;79(2):219-28, discussion 21A-22A. doi: 10.1097/00000542-199308000-00005.
PubMed 8342834Sessler DI, Moayeri A. Skin-surface warming: heat flux and central temperature. Anesthesiology. 1990 Aug;73(2):218-24.
PubMed 2382847Neubauer RA, James P. Cerebral oxygenation and the recoverable brain. Neurol Res. 1998;20 Suppl 1:S33-6. doi: 10.1080/01616412.1998.11740606.
PubMed 9584921Vanni SM, Braz JR, Modolo NS, Amorim RB, Rodrigues GR Jr. Preoperative combined with intraoperative skin-surface warming avoids hypothermia caused by general anesthesia and surgery. J Clin Anesth. 2003 Mar;15(2):119-25. doi: 10.1016/s0952-8180(02)00512-3.
PubMed 12719051Kurz A, Kurz M, Poeschl G, Faryniak B, Redl G, Hackl W. Forced-air warming maintains intraoperative normothermia better than circulating-water mattresses. Anesth Analg. 1993 Jul;77(1):89-95. doi: 10.1213/00000539-199307000-00018.
PubMed 8317754Matsuzaki Y, Matsukawa T, Ohki K, Yamamoto Y, Nakamura M, Oshibuchi T. Warming by resistive heating maintains perioperative normothermia as well as forced air heating. Br J Anaesth. 2003 May;90(5):689-91. doi: 10.1093/bja/aeg106.
PubMed 12697600Torrie JJ, Yip P, Robinson E. Comparison of forced-air warming and radiant heating during transurethral prostatic resection under spinal anaesthesia. Anaesth Intensive Care. 2005 Dec;33(6):733-8. doi: 10.1177/0310057X0503300605.
PubMed 16398377
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre Warming Protocol Implementation Strategy in the Operation Room Routine
- ClinicalTrials.gov ID
- NCT05573152
- Acronym / sponsor ID
- Parecer 699.971
- Conditions
- Hypothermia
- Keywords
- Body Temperature, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Oct 2022 (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.
Literature establishes that warming with a heated blanket before and during the operation is effective in the prevention of perioperative hypothermia, both in general anesthesia as well as spinal anesthesia. However, the trials have still not presented us with objective protocols to standardize this routine in the surgical centers.
The study aims to assess the adoption and reproduction of the implementation of the warning device by the nursing team immediately after the patient's entrance in the operating room, even before the entrance of the anesthesiologist.
Detailed description
After approval by the Institutional Research Ethics Committee, the patients for elective surgeries to be submitted to general and spinal anesthesia lasting 60 minutes or more held at the central operating center at Santa Casa de Misericórdia in São Paulo will be assessed over a period of 60 days. The patients will receive the necessary explanations on the research and, after obtaining the responsible consent for participating in the trial, they will be included.
Inclusion/exclusion criteria:
Inclusion - adults that will be submitted to general or spinal anesthesia in the central operating center at Santa Casa de Misericórdia in São Paulo.
Exclusion:
- Patient over 18 years old;
- Patients that are feverish/present with infectious symptoms
- Refusal of the use of the device by the patient
- Patient that does not tolerate the use of the blanket in the pre op. The study aims to assess over a period of 60 days the compliance to the protocol and the prewarming time with the use of the heated air flow device from the moment the patients enter the operating room until anesthesia induction. The heating device will be set up connected to the patient and to the motor with the activation of the system at 43°C by the nursing team. The monitoring of the times since the entrance of the patient in the operating room until the induction of the anesthesia will be controlled by a member of the anesthesia team (regardless of the room process).
All the patients scheduled with elective surgery predicted to last over 60 minutes will be selected and there will be an assessment of the number of cases in which the protocol was followed and the time of use of the warming device will be monitored from the installation entrance in the OR and before the anesthesia induction and every 30 minutes beginning of anesthesia, during the surgery until the end of the anesthetic procedure.
The variables to be assessed in the study are:
- Age, gender, weight, height, body mass index (BMI), diseases, physical condition according to the American Anesthesiology Association classification;
- Oral temperature measured at the following points:
- M-entrance - entering the room and installation of the blanket
- M-ind - from the moment after the induction of anesthesia;
- M30, M60, M90, M120 = 30, 60, 90, 120 min after induction till the end of the anesthetic procedure; and the patients scheduled to general anesthesia will be also measured with esophagus thermometer
- The protocol establishes the types of warm blankets available to be used for the different types of surgery;
- Arterial oxygen saturation; heart beat; systolic and diastolic pressure and carbon dioxide expired:
- At the entrance of the operating room;
- Immediately after induction;
- Every 30 minutes after induction until the patient leaves the operating room;
- The type of surgery and anesthesia will be assessed among the pre-warming groups
- Room temperature will be measured (at the entrance of the patient and after induction and at the end of surgery/anesthesia;
- Presence of side effects. The need of blood transfusion will be assessed during surgery. There will be statistical assessment of the results, the significant statistical difference will be p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing | Experimental | Procedure: Control, Procedure: NursingNursing Group (Nurse): the nursing team will use of the warming device air flow device from the moment the patients enter the operating room until anesthesia induction. The warming device will be set up connected to the patient and to the motor with the activation of the system at 43°C by the nursing team. The monitoring of the times since the entrance of the patient in the operating room until the induction of the anesthesia will be controlled by a member of the anesthesia team (regardless of the room process); |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults that will be submitted to general or spinal anesthesia in the surgical center of hospital central at Santa Casa de Misericórdia in São Paulo
Key exclusion criteria (4 listed)
- Patient under 18 years old;
- Patients that are feverish/present with infectious symptoms
- Refusal of the use of the device by the patient
- Patient that does not tolerate the use of the blanket in the pre op.
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 |
|---|---|---|
| ControlAll previously selected patients will be under passive warming by means of blankets | Procedure or surgery | Nursing |
| NursingAll previously selected patients will be under active air flow warming device at 43 Celsius | Procedure or surgery | Nursing |
Primary outcome
Body temperature
Time frame: 120 minutes
temperature from entrance in surgical room to ending of anesthesia state
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 10 Oct 2022.
- Results publication: PubMed 7197479Vaughan MS, Vaughan RW, Cork RC. Postoperative hypothermia in adults: relationship of age, anesthesia, and shivering to rewarming. Anesth Analg. 1981 Oct;60(10):746-51.
- Results publication: PubMed 9100967Sessler DI. Perioperative thermoregulation and heat balance. Ann N Y Acad Sci. 1997 Mar 15;813:757-77. doi: 10.1111/j.1749-6632.1997.tb51779.x.
- Results publication: PubMed 7879936Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.
- Results publication: PubMed 2008950Hynson JM, Sessler DI, Glosten B, McGuire J. Thermal balance and tremor patterns during epidural anesthesia. Anesthesiology. 1991 Apr;74(4):680-90. doi: 10.1097/00000542-199104000-00011.
- Results publication: PubMed 7879935Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.
- Results publication: PubMed 7168548Hendolin H, Lansimies E. Skin and central temperatures during continuous epidural analgesia and general anaesthesia in patients subjected to open prostatectomy. Ann Clin Res. 1982 Aug;14(4):181-6.
- Results publication: PubMed 17342966Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
- Results publication: PubMed 7661349Kurz A, Sessler DI, Christensen R, Dechert M. Heat balance and distribution during the core-temperature plateau in anesthetized humans. Anesthesiology. 1995 Sep;83(3):491-9. doi: 10.1097/00000542-199509000-00007.
- Results publication: PubMed 8342834Hynson JM, Sessler DI, Moayeri A, McGuire J, Schroeder M. The effects of preinduction warming on temperature and blood pressure during propofol/nitrous oxide anesthesia. Anesthesiology. 1993 Aug;79(2):219-28, discussion 21A-22A. doi: 10.1097/00000542-199308000-00005.
- Results publication: PubMed 2382847Sessler DI, Moayeri A. Skin-surface warming: heat flux and central temperature. Anesthesiology. 1990 Aug;73(2):218-24.
- Results publication: PubMed 9584921Neubauer RA, James P. Cerebral oxygenation and the recoverable brain. Neurol Res. 1998;20 Suppl 1:S33-6. doi: 10.1080/01616412.1998.11740606.
- Results publication: PubMed 12719051Vanni SM, Braz JR, Modolo NS, Amorim RB, Rodrigues GR Jr. Preoperative combined with intraoperative skin-surface warming avoids hypothermia caused by general anesthesia and surgery. J Clin Anesth. 2003 Mar;15(2):119-25. doi: 10.1016/s0952-8180(02)00512-3.
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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.
Ricardo Caio G De Bernardis, MD, Ph.D principal investigator
Irmandade Santa Casa deMisericórdia de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing in people with Hypothermia, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 4 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 10 Oct 2022. 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 Brazil. 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?
Body temperature (time frame: 120 minutes). 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 NCT05573152, which also lists 17 linked publications.
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 10 Oct 2022.