Comparisons of Two Different Type Heater in Different Inhalation Anesthesia in Terms of Prevention of Hypothermia

Sponsor
Fatih Sultan Mehmet Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06107647
Collaborator
(none)
112
1
4
9
12.4

Study Details

Study Description

Brief Summary

Unintentional perioperative hypothermia is a common occurrence. One of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. It is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. In this study, we aimed to compare the efficacy of using active air blown heater and resistive heater in preventing hypothermia in patients with low flow and high flow inhalation anesthesia

Condition or Disease Intervention/Treatment Phase
  • Device: COVIDIEN WarmTouch
N/A

Detailed Description

ABSTRACT

PROSPECTIVE COMPARISON OF ACTIVE AIR BLOWN HEATER AND RESISTIVE TYPE HEATERS FOR PREVENTION OF HYPOTHERMIA IN HIGH CURRENT AND LOW CURRENT INHALATION ANESTHESIA

Aim: Unintentional perioperative hypothermia is a common occurrence. One of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. It is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. In this study, we aimed to compare the efficacy of using active air blown heater and resistive heater in preventing hypothermia in patients with low flow and high flow inhalation anesthesia.

Materials and Methods: After ethics committee approval (Date: 08.12.2022/23), 112 patients with American Society of Anesthesiologist (ASA; American Society of Anesthesiologists) I-III, who were to undergo rhinoplasty between June 01, 2023 and January 01, 2024, were included in the study after informed consent was obtained. Group DA was defined as low flow anesthesia and active air blast heater, group DR as low flow anesthesia and resistive heater, group YA as high flow anesthesia and active air blast heater, and group YR as high flow anesthesia and resistive heater. Each group consisted of 28 patients. Heart rate, systolic, diastolic and mean arterial pressure, peripheral oxygen saturation values and body temperature values were measured and recorded at certain time intervals during the perioperative period and in the recovery unit. Body temperatures were also recorded in the ward. Thermal comfort scores were evaluated on admission, in the recovery unit and in the ward, while shivering score and patient satisfaction score were evaluated only in the recovery unit.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Prospective Comparisons of Active Air Blow Heaters and Resistive Type Heaters in High-current and Low-current Inhalation Anesthesia in Terms of the Prevention of Hypothermia
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: GRUP DA

Patients who will be given low-flow anesthesia during the operation and will be heated with an active air blower heater.

Device: COVIDIEN WarmTouch
"COVIDIEN WarmTouch will be used as an active air blowing heater. Patients will be warmed starting from the beginning of anesthesia." "The INDITHERM Medical Alpha, which is a resistive heater, will be applied to patients starting at the beginning of anesthesia."
Other Names:
  • INDITHERM Medical Alpha
  • Experimental: GRUP YA

    Patients who will be given high current anesthesia during the operation and will be heated with an active air blower heater.

    Device: COVIDIEN WarmTouch
    "COVIDIEN WarmTouch will be used as an active air blowing heater. Patients will be warmed starting from the beginning of anesthesia." "The INDITHERM Medical Alpha, which is a resistive heater, will be applied to patients starting at the beginning of anesthesia."
    Other Names:
  • INDITHERM Medical Alpha
  • Experimental: GRUP DR

    Patients who will be given low-flow anesthesia during the operation and will be heated with a resistive heater

    Device: COVIDIEN WarmTouch
    "COVIDIEN WarmTouch will be used as an active air blowing heater. Patients will be warmed starting from the beginning of anesthesia." "The INDITHERM Medical Alpha, which is a resistive heater, will be applied to patients starting at the beginning of anesthesia."
    Other Names:
  • INDITHERM Medical Alpha
  • Experimental: GRUP YR

    Patients who will be treated with high-flow anesthesia and heated with a resistive heater during the operation

    Device: COVIDIEN WarmTouch
    "COVIDIEN WarmTouch will be used as an active air blowing heater. Patients will be warmed starting from the beginning of anesthesia." "The INDITHERM Medical Alpha, which is a resistive heater, will be applied to patients starting at the beginning of anesthesia."
    Other Names:
  • INDITHERM Medical Alpha
  • Outcome Measures

    Primary Outcome Measures

    1. Measurement of body temperatures in patients using two different body heaters during anesthesia applications. [6 mounth]

      In our study, two patient groups receiving high current and low current anesthesia will be heated with only one type of heater, either active air blowing heater or resistive heater, from the beginning of anesthesia. Their body temperatures will be measured and recorded throughout the operation. In our study, COVIDIEN WarmTouch will be used as an active air blowing heater. INDITHERM Medical Alpha will be used as a resistive-type heater. Throughout the entire operation, body temperature will be monitored using the zero-heat flow method from the temporal artery to the body surface (3M Spot ON).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients between the ages of 18-65, who are included in the ASA I-III group, who will undergo rhinoplasty.
    Exclusion Criteria:
    • Patients with BMI > 35 KG/M²

    • Patients with body temperature >37.5°C, <36°C degrees

    • Those with cardiovascular system or central nervous system disease

    • Patients with thyroid disorders

    • Patients with autonomic dysfunction

    • Patients not between the ages of 18-65

    • Patients with missing information in the information form

    • Patients using steroids or vasoactive drugs.

    • Patients whose operation time is less than 30 minutes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abdullah Pabucci Istanbul Turkey

    Sponsors and Collaborators

    • Fatih Sultan Mehmet Training and Research Hospital

    Investigators

    • Principal Investigator: abdullah pabucci, fatih sultan mehmet research and traning hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdullah Pabucci, Assistant Doctor, Fatih Sultan Mehmet Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT06107647
    Other Study ID Numbers:
    • ABDULLAHPABUCCI1
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 31, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Abdullah Pabucci, Assistant Doctor, Fatih Sultan Mehmet Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 31, 2023