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

NCT ID: NCT06107647

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-03-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Anesthesia Hypothermia Heat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GRUP DA

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

Group Type EXPERIMENTAL

COVIDIEN WarmTouch

Intervention Type DEVICE

"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."

GRUP YA

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

Group Type EXPERIMENTAL

COVIDIEN WarmTouch

Intervention Type DEVICE

"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."

GRUP DR

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

Group Type EXPERIMENTAL

COVIDIEN WarmTouch

Intervention Type DEVICE

"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."

GRUP YR

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

Group Type EXPERIMENTAL

COVIDIEN WarmTouch

Intervention Type DEVICE

"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."

Interventions

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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."

Intervention Type DEVICE

Other Intervention Names

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INDITHERM Medical Alpha

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Abdullah Pabucci

Assistant Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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abdullah pabucci

Role: PRINCIPAL_INVESTIGATOR

fatih sultan mehmet research and traning hospital

Locations

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Abdullah Pabucci

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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abdullah md pabucci

Role: CONTACT

+905531918241

arzu md yıldırım ar

Role: CONTACT

+905053822729

Facility Contacts

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abdullah md pabucci

Role: primary

+905531918241

arzu md yıldırım ar

Role: backup

+905053822729

Other Identifiers

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ABDULLAHPABUCCI1

Identifier Type: -

Identifier Source: org_study_id

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