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Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery

Primary Purpose

Inadvertent Perioperative Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Forced Air Warming
Peripheral Carbon Fiber Warming
Sponsored by
Bozok University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inadvertent Perioperative Hypothermia focused on measuring Inadvertent Perioperative Hypothermia, laparoscopic cholecystectomy, nurse, pain, physiological parameters, shivering, thermal comfort

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients are qualified to answer research questions,
  • BMI is between 18.5 kg / m2 and 30 kg / m2,
  • Not using therapeutic hypothermia in the surgery,
  • Not being treated with chronic opioids,
  • Operation time is between 60 minutes and 6 hours,
  • Having received general anesthesia during the operation,
  • Reception of patients with ASA classification I or II,
  • Absence of anemia, coagulation problem and peripheral circulatory disease or metabolic disease.

Exclusion Criteria:

  • Intraoperative and postoperative have complications (bleeding, arrest, nausea, vomiting, etc.),
  • Conversion of surgery from laparoscopy to open surgery.

Sites / Locations

  • Yozgat Bozok University Health Sciences Faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Forced Air Warming Group

Peripheral Carbon Fiber Warming Group

Control Group

Arm Description

There is no intervention in patients before the operation. When he comes out of the operation and comes to the post-anesthesia care unit (PACU), he is warmed by forced air. When the body temperature of the patients reaches 36 ° C, they are transferred to the clinic with a cover and blanket.

Gloves and socks developed by the researcher are applied half an hour before the operation. These materials, called environmental warming, have three layers. The first layer in contact with the patient is a thermal inner sheath made of 90% Polyester and 10% Polyamide and is used to maintain body temperature. The second layer consists of carbon fiber warmer and foil. The end of the carbon fiber warmer is USB connected. When the connection is plugged in, the warmer works. The third layer is again made of thermal fabric. A rubber bandage is made to separate the last layer from the external environment and to maintain the patient's body temperature. The USB connection is removed while patients are sent for surgery. After the operation, rewarming is started in the post-anesthesia care unit. When the patient's body temperature reaches 36 ° C, he is transferred to the clinic with a cover and blanket.

A routine hospital procedure is applied. The patient is not warmed before going to surgery. A cover and blanket are used passively after being taken to the PACU from the operation.

Outcomes

Primary Outcome Measures

Pain Visual Analog Scale
The Visual Pain Scale is a scale of ten centimeters, created to inquire about the pain status of individuals. Zero indicates no pain while ten indicates the most severe pain. This chart is prepared as a blank line for self-evaluation and the prepared chart is read on the ruler.
Thermal Comfort Visual Analog Scale
Horn et al. It is a visual assessment scale developed by. Thermal comfort is evaluated using a 100 mm long visual benchmark scale. Zero points represent the worst unbearable cold, 50 mm thermal comfort, 100 mm unbearable temperature. Objective responses of the patients were determined by making an evaluation from 0 to 100mm.
Body Temperature Scale
It is the measurement chart prepared by the researcher. Includes measurement of body temperature over time.

Secondary Outcome Measures

Tremor Rating Scale
Badjatia et al. it is a visual assessment scale developed by. The tremor intensity rating scale is a visual evaluation scale that is observed and evaluated by researchers. When the quality of the tremor is evaluated numerically; 0: no flickering; 1: tremor localized in the abdomen and neck; 2: tremors, including upper limbs; and 3: whole body tremors.
Hemoglobin Parameters Scale
Hemoglobin Parameters include leves at blood. Indicates the intraoperative bleeding level.
International Normalized Ratio Parameters Scale
International Normalized Ratio Parameters include Pt INR leves at blood. Indicates the intraoperative bleeding risk of patients.

Full Information

First Posted
January 27, 2021
Last Updated
February 28, 2022
Sponsor
Bozok University
Collaborators
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04741815
Brief Title
Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery
Official Title
The Effect of Different Warming Methods Applied to Patients for Prevention of Hypothermia on Pain, Comfort and Some Parameters in Laparoscopic Cholecystectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozok University
Collaborators
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cold gases given during laparoscopic cholecystectomy are the most important cause of hypothermia. However, even surgery alone is an 80% important cause of hypothermia. Inadvertent perioperative hypothermia is a common complication of the surgical process that can cause serious complications. In most of the patients, tremors, increase in pain, deterioration in comfort and changes in some physiological parameters can be seen. Despite this, there are not enough warming devices that nurses can use practically and are easy to use, affordable and comfortable for the patient. In the literature, it is stated in the evidence-based guidelines for determining the hypothermia risks of patients and taking early precautions.
Detailed Description
The parallel group randomized controlled three group study blinded by the evaluator aims to investigate the effectiveness of different warming methods in laparoscopic cholecystectomy patients. This study general surgery at Yozgat Bozok University Hospital in Turkey are performed in clinics. All patients are male and female patients who have undergone surgery and met the inclusion criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inadvertent Perioperative Hypothermia
Keywords
Inadvertent Perioperative Hypothermia, laparoscopic cholecystectomy, nurse, pain, physiological parameters, shivering, thermal comfort

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forced Air Warming Group
Arm Type
Experimental
Arm Description
There is no intervention in patients before the operation. When he comes out of the operation and comes to the post-anesthesia care unit (PACU), he is warmed by forced air. When the body temperature of the patients reaches 36 ° C, they are transferred to the clinic with a cover and blanket.
Arm Title
Peripheral Carbon Fiber Warming Group
Arm Type
Experimental
Arm Description
Gloves and socks developed by the researcher are applied half an hour before the operation. These materials, called environmental warming, have three layers. The first layer in contact with the patient is a thermal inner sheath made of 90% Polyester and 10% Polyamide and is used to maintain body temperature. The second layer consists of carbon fiber warmer and foil. The end of the carbon fiber warmer is USB connected. When the connection is plugged in, the warmer works. The third layer is again made of thermal fabric. A rubber bandage is made to separate the last layer from the external environment and to maintain the patient's body temperature. The USB connection is removed while patients are sent for surgery. After the operation, rewarming is started in the post-anesthesia care unit. When the patient's body temperature reaches 36 ° C, he is transferred to the clinic with a cover and blanket.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
A routine hospital procedure is applied. The patient is not warmed before going to surgery. A cover and blanket are used passively after being taken to the PACU from the operation.
Intervention Type
Device
Intervention Name(s)
Forced Air Warming
Intervention Description
It consists of the WarmAir® unit and FilteredFlo® blankets. FilteredFlo® blankets are a cover designed to cover the entire body and extremities with air channels that provide the appropriate distribution of patient warm. The WarmAir® warming device connected to the shroud via a pipe; it has three temperature settings, 32.2 C, 37.8 C, and 43.3 C.
Intervention Type
Device
Intervention Name(s)
Peripheral Carbon Fiber Warming
Intervention Description
It was developed by the researcher. Designed as gloves and socks, these warming materials have three layers. The first layer in contact with the patient and the third layer in contact with the external environment is a thermal material to maintain body temperature. The second floor consists of a USB-connected carbon fiber warmer and foil.
Primary Outcome Measure Information:
Title
Pain Visual Analog Scale
Description
The Visual Pain Scale is a scale of ten centimeters, created to inquire about the pain status of individuals. Zero indicates no pain while ten indicates the most severe pain. This chart is prepared as a blank line for self-evaluation and the prepared chart is read on the ruler.
Time Frame
It is measured preoperatively and after the end of the operation at the 30th minute, 12th hour and 24th hour (up to 24 hours). Change from baseline Pain Visual Analog Scale scores at 24 hours.
Title
Thermal Comfort Visual Analog Scale
Description
Horn et al. It is a visual assessment scale developed by. Thermal comfort is evaluated using a 100 mm long visual benchmark scale. Zero points represent the worst unbearable cold, 50 mm thermal comfort, 100 mm unbearable temperature. Objective responses of the patients were determined by making an evaluation from 0 to 100mm.
Time Frame
It is measured before surgery and every half hour after surgery (up to 2 hours). The change in thermal comfort score before and within the first two hours after surgery is recorded.
Title
Body Temperature Scale
Description
It is the measurement chart prepared by the researcher. Includes measurement of body temperature over time.
Time Frame
It is measured before surgery and every fifteen minutes after surgery (up to 2 hours). The change in Body Temperature Scale score before and within the first two hours after surgery is recorded.
Secondary Outcome Measure Information:
Title
Tremor Rating Scale
Description
Badjatia et al. it is a visual assessment scale developed by. The tremor intensity rating scale is a visual evaluation scale that is observed and evaluated by researchers. When the quality of the tremor is evaluated numerically; 0: no flickering; 1: tremor localized in the abdomen and neck; 2: tremors, including upper limbs; and 3: whole body tremors.
Time Frame
It is measured before and every 15 minutes after surgery (up to 1 hour). Changes in tremor from the first minute to an hour after surgery.
Title
Hemoglobin Parameters Scale
Description
Hemoglobin Parameters include leves at blood. Indicates the intraoperative bleeding level.
Time Frame
The hemoglobin level is measured before surgery and at 24th hours after surgery (up to 24 hours). Change from baseline hemoglobin level scores at 24 hours.
Title
International Normalized Ratio Parameters Scale
Description
International Normalized Ratio Parameters include Pt INR leves at blood. Indicates the intraoperative bleeding risk of patients.
Time Frame
The Pt INR level is measured before surgery and at 1th hours after surgery (up to 1 hours). Change from preoperative Pt INR level at postoperative 1st hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients are qualified to answer research questions, BMI is between 18.5 kg / m2 and 30 kg / m2, Not using therapeutic hypothermia in the surgery, Not being treated with chronic opioids, Operation time is between 60 minutes and 6 hours, Having received general anesthesia during the operation, Reception of patients with ASA classification I or II, Absence of anemia, coagulation problem and peripheral circulatory disease or metabolic disease. Exclusion Criteria: Intraoperative and postoperative have complications (bleeding, arrest, nausea, vomiting, etc.), Conversion of surgery from laparoscopy to open surgery.
Facility Information:
Facility Name
Yozgat Bozok University Health Sciences Faculty
City
Yozgat
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery

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