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Pre Warming Protocol Implementation in Operation Room

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control
Nursing
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring Body Temperature, Hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculdade de Ciencias Medicas da Santa Casa de São Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nursing

Arm Description

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);

Outcomes

Primary Outcome Measures

Body temperature
temperature from entrance in surgical room to ending of anesthesia state

Secondary Outcome Measures

Full Information

First Posted
June 17, 2015
Last Updated
October 5, 2022
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05573152
Brief Title
Pre Warming Protocol Implementation in Operation Room
Official Title
Pre Warming Protocol Implementation Strategy in the Operation Room Routine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
Body Temperature, Hypothermia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nursing
Arm Type
Experimental
Arm Description
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);
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
All previously selected patients will be under passive warming by means of blankets
Intervention Type
Procedure
Intervention Name(s)
Nursing
Intervention Description
All previously selected patients will be under active air flow warming device at 43 Celsius
Primary Outcome Measure Information:
Title
Body temperature
Description
temperature from entrance in surgical room to ending of anesthesia state
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Caio G De Bernardis, MD, Ph.D
Organizational Affiliation
Irmandade Santa Casa deMisericórdia de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Ciencias Medicas da Santa Casa de São Paulo
City
São Paulo
ZIP/Postal Code
01220-021
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
7197479
Citation
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.
Results Reference
result
PubMed Identifier
9100967
Citation
Sessler 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 Reference
result
PubMed Identifier
7879936
Citation
Sessler 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 Reference
result
PubMed Identifier
2008950
Citation
Hynson 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 Reference
result
PubMed Identifier
7879935
Citation
Matsukawa 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 Reference
result
PubMed Identifier
7168548
Citation
Hendolin 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 Reference
result
PubMed Identifier
17342966
Citation
Insler 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 Reference
result
PubMed Identifier
7661349
Citation
Kurz 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 Reference
result
PubMed Identifier
8342834
Citation
Hynson 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 Reference
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PubMed Identifier
2382847
Citation
Sessler DI, Moayeri A. Skin-surface warming: heat flux and central temperature. Anesthesiology. 1990 Aug;73(2):218-24.
Results Reference
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PubMed Identifier
9584921
Citation
Neubauer RA, James P. Cerebral oxygenation and the recoverable brain. Neurol Res. 1998;20 Suppl 1:S33-6. doi: 10.1080/01616412.1998.11740606.
Results Reference
result
PubMed Identifier
12719051
Citation
Vanni 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.
Results Reference
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PubMed Identifier
8317754
Citation
Kurz 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.
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PubMed Identifier
12697600
Citation
Matsuzaki 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.
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PubMed Identifier
16398377
Citation
Torrie 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.
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PubMed Identifier
1610573
Citation
Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8.
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PubMed Identifier
22376088
Citation
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Results Reference
result

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Pre Warming Protocol Implementation in Operation Room

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