Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery

• ClinicalTrials.gov Identifier: NCT04741815
• Recruitment Status: Completed
• First Posted: February 5, 2021
• Last Update Posted: March 2, 2022
• Sponsor: Bozok University
• Collaborator: Ataturk University
• Information provided by (Responsible Party): Aybike Bahçeli, Bozok University

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.

Condition or disease	Intervention/treatment	Phase
Inadvertent Perioperative Hypothermia	Device: Forced Air Warming; Device: Peripheral Carbon Fiber Warming	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: January 22, 2019
• Actual Primary Completion Date: March 20, 2021
• Actual Study Completion Date: April 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Forced Air Warming Group; 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.	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.
Experimental: Peripheral Carbon Fiber Warming Group; 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.	Device: 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.
No Intervention: Control Group; 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.

Outcome Measures

Primary Outcome Measures :

1. Pain Visual Analog Scale [ 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. ]
   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.
2. Thermal Comfort Visual Analog Scale [ 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. ]
   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.
3. Body Temperature Scale [ 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. ]
   It is the measurement chart prepared by the researcher. Includes measurement of body temperature over time.

Secondary Outcome Measures :

1. Tremor Rating Scale [ 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. ]
   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.
2. Hemoglobin Parameters Scale [ 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. ]
   Hemoglobin Parameters include leves at blood. Indicates the intraoperative bleeding level.
3. International Normalized Ratio Parameters Scale [ 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. ]
   International Normalized Ratio Parameters include Pt INR leves at blood. Indicates the intraoperative bleeding risk of patients.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Turkey

Yozgat Bozok University Health Sciences Faculty

Yozgat, Turkey

Sponsors and Collaborators

Bozok University

Ataturk University

More Information

• Responsible Party: Aybike Bahçeli, Research Asistant, Bozok University
• ClinicalTrials.gov Identifier: NCT04741815
• Other Study ID Numbers: 2018-3/16
• First Posted: February 5, 2021
• Last Update Posted: March 2, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aybike Bahçeli, Bozok University:

Inadvertent Perioperative Hypothermia; laparoscopic cholecystectomy; nurse; pain; physiological parameters; shivering; thermal comfort

Additional relevant MeSH terms:

Hypothermia; Body Temperature Changes; Carbon Fiber; Anti-Infective Agents, Local; Anti-Infective Agents