Pre Warming Protocol Implementation in Operation Room

October 5, 2022 updated by: Faculdade de Ciências Médicas da Santa Casa de São Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01220-021
        • Faculdade de Ciências Médicas da Santa Casa de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nursing
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);
Procedure: Control
All previously selected patients will be under passive warming by means of blankets
Procedure: Nursing
All previously selected patients will be under active air flow warming device at 43 Celsius

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body temperature
Time Frame: 120 minutes
temperature from entrance in surgical room to ending of anesthesia state
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

  • Principal Investigator: Ricardo Caio G De Bernardis, MD, Ph.D, Irmandade Santa Casa deMisericórdia de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parecer 699.971

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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