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

NCT06107647 | Unknown DMC

• 1 other identifier: ABDULLAHPABUCCI1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia; Hypothermia; Heat

Keywords

High flow; hypothermia; low flow; rhinoplasty

Outcome Measures

Primary Outcomes (1)

• Measurement of body temperatures in patients using two different body heaters during anesthesia applications.

  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).

  6 mounth

Study Arms (4)

GRUP DA

EXPERIMENTAL

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

Device: COVIDIEN WarmTouch

GRUP YA

EXPERIMENTAL

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

Device: COVIDIEN WarmTouch

GRUP DR

EXPERIMENTAL

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

Device: COVIDIEN WarmTouch

GRUP YR

EXPERIMENTAL

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

Device: COVIDIEN WarmTouch

Interventions

COVIDIEN WarmTouch 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."

Also known as: INDITHERM Medical Alpha

GRUP DA; GRUP DR; GRUP YA; GRUP YR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18-65, who are included in the ASA I-III group, who will undergo rhinoplasty.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Abdullah Pabucci

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• abdullah pabucci

  fatih sultan mehmet research and traning hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

abdullah md pabucci

CONTACT

+905531918241; dr.pabucci@gmail.com

arzu md yıldırım ar

CONTACT

+905053822729; dr.arzuyildirim@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: October 30, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)