Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery

Inadvertent Perioperative Hypothermia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741815
• Other study ID #: 2018-3/16
• Status: Completed
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2022
• Source: Bozok University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 30, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothermia
• Inadvertent Perioperative Hypothermia

Intervention

Device:
• Forced Air Warming
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.
• Peripheral Carbon Fiber Warming
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.

Locations

Country	Name	City	State
Turkey	Yozgat Bozok University Health Sciences Faculty	Yozgat

Sponsors (2)

Lead Sponsor	Collaborator
Bozok University	Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.
Primary	Body Temperature Scale	It is the measurement chart prepared by the researcher. Includes measurement of body temperature over time.	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	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.	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.
Secondary	Hemoglobin Parameters Scale	Hemoglobin Parameters include leves at blood. Indicates the intraoperative bleeding level.	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.
Secondary	International Normalized Ratio Parameters Scale	International Normalized Ratio Parameters include Pt INR leves at blood. Indicates the intraoperative bleeding risk of patients.	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.